<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711216</url>
  </required_header>
  <id_info>
    <org_study_id>P13-688</org_study_id>
    <nct_id>NCT01711216</nct_id>
  </id_info>
  <brief_title>Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan</brief_title>
  <official_title>A Post-Marketing, Prospective, Multicenter, Observational Program: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan&#xD;
      and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for&#xD;
      management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,&#xD;
      dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,&#xD;
      infertility due to luteal insufficiency, as well as part of hormone replacement therapy.&#xD;
      There are limited data regarding dydrogesterone's role in achieving cycle regularization from&#xD;
      post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in&#xD;
      a post-marketing setting after cessation of treatment and whether the persistence, if any, is&#xD;
      related to the duration of dydrogesterone therapy. Hence, in this observational program, the&#xD;
      goal is to observe the possible implications of such treatment in terms of treatment length&#xD;
      and response pattern.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The program is designed as a prospective, multicentre, observational, non-interventional,&#xD;
      non-randomized, non-controlled, single arm, post-marketing program. Being an observational&#xD;
      program, the assignment of patients to dydrogesterone therapy will not be decided with an&#xD;
      intention to include patients in the program, but will be guided as per standard clinical&#xD;
      practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly&#xD;
      separate from the decision to include patients in this program. All dydrogesterone&#xD;
      prescriptions will be made in accordance with locally approved package insert for&#xD;
      dydrogesterone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Polymenorrhea was defined as cycle duration &lt; 21 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Polymenorrhea is defined as cycle duration &lt; 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Pain Intensity During Menstruation From Baseline to End of Treatment</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Intensity of Anxiety From Baseline to the End of Treatment</measure>
    <time_frame>From 1 month to 6 months</time_frame>
    <description>Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With the Treatment</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Clinical Response on Treatment Assessed by Physician</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea</measure>
    <time_frame>From 1 month to 12 months</time_frame>
    <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration &lt; 21 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea</measure>
    <time_frame>From 1 month to 12 months</time_frame>
    <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration &gt; 35 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Pain Intensity During Menstruation</measure>
    <time_frame>From 1 month to 12 months</time_frame>
    <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Intensity of Anxiety</measure>
    <time_frame>From 1 month to 12 months</time_frame>
    <description>Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Relapse</measure>
    <time_frame>Up to 6 months or longer after ended treatment</time_frame>
    <description>The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">999</enrollment>
  <condition>Irregular Menstrual Cycle</condition>
  <arm_group>
    <arm_group_label>women received dydrogesterone for irregular menstrual cycle</arm_group_label>
    <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        women with irregular menstrual cycle due to progesterone deficiency&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Women aged 18-40 years&#xD;
&#xD;
          -  Irregular menstrual cycle due to progesterone deficiency for at least 3 months&#xD;
&#xD;
          -  Dydrogesterone prescribed in accordance with locally approved package insert&#xD;
&#xD;
          -  Signed written authorization to provide data for the program&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known hypersensitivity to the active ingredient or excipients&#xD;
&#xD;
          -  Known or suspected progesterone-dependent neoplasms&#xD;
&#xD;
          -  Vaginal bleeding of unknown etiology&#xD;
&#xD;
          -  Administration of oral contraceptives&#xD;
&#xD;
          -  Any other condition that precludes use of dydrogesterone in a particular patient, in&#xD;
             accordance with the contraindication, precautions and special warnings listed in the&#xD;
             locally approve package insert (for example, patients with rare hereditary problems of&#xD;
             galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Pexman-Fieth, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site reference ID/Investiagor# 82286</name>
      <address>
        <city>Aktobe</city>
        <zip>030000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investiagor# 82287</name>
      <address>
        <city>Aktobe</city>
        <zip>030000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 101795</name>
      <address>
        <city>Aktobe</city>
        <zip>030000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 101799</name>
      <address>
        <city>Aktobe</city>
        <zip>030000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82279</name>
      <address>
        <city>Aktobe</city>
        <zip>030000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 101798</name>
      <address>
        <city>Aktobe</city>
        <zip>030019</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investiagor# 82281</name>
      <address>
        <city>Almaty</city>
        <zip>050000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82293</name>
      <address>
        <city>Almaty</city>
        <zip>050009</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 101796</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 101797</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82277</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82299</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82300</name>
      <address>
        <city>Astana</city>
        <zip>010000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82301</name>
      <address>
        <city>Astana</city>
        <zip>10000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investiagor# 82282</name>
      <address>
        <city>Shymkent</city>
        <zip>160000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82275</name>
      <address>
        <city>Shymkent</city>
        <zip>160000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82288</name>
      <address>
        <city>Shymkent</city>
        <zip>160000</zip>
        <country>Kazakhstan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82035</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaotr# 76702</name>
      <address>
        <city>Irkutsk</city>
        <zip>664003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 77753</name>
      <address>
        <city>Kazan</city>
        <zip>420043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaotr# 76704</name>
      <address>
        <city>Kemerovo</city>
        <zip>650029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 76701</name>
      <address>
        <city>Krasnodar</city>
        <zip>350063 RF</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88537</name>
      <address>
        <city>Moscow</city>
        <zip>101000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaotr# 76708</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 76700</name>
      <address>
        <city>Moscow</city>
        <zip>121243</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 87013</name>
      <address>
        <city>Moscow</city>
        <zip>127018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88535</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88514</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <zip>603057</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 83633</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88536</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaotr# 76709</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 77754</name>
      <address>
        <city>St. Petersburg</city>
        <zip>195257</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaotr# 76705</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 77755</name>
      <address>
        <city>Tumen</city>
        <zip>625002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 82036</name>
      <address>
        <city>Volgograd</city>
        <zip>400008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88513</name>
      <address>
        <city>Voronezh</city>
        <zip>394036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 75815</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75816</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference #/Investigator ID 77816</name>
      <address>
        <city>Kharkiv</city>
        <zip>61050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 75817</name>
      <address>
        <city>Kharkiv</city>
        <zip>61075</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 75813</name>
      <address>
        <city>Kiev</city>
        <zip>01034</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75814</name>
      <address>
        <city>Kiev</city>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 88056</name>
      <address>
        <city>Lviv</city>
        <zip>79032</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 75819</name>
      <address>
        <city>Mykolaiv</city>
        <zip>54058</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 77817</name>
      <address>
        <city>Odesa</city>
        <zip>65000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 80193</name>
      <address>
        <city>Odesa</city>
        <zip>65039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 77813</name>
      <address>
        <city>Ternopil</city>
        <zip>46020</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 75818</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 75822</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69071</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91973</name>
      <address>
        <city>Andijan</city>
        <zip>170000</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91974</name>
      <address>
        <city>Andijan</city>
        <zip>170100</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91987</name>
      <address>
        <city>Bukhara</city>
        <zip>705000</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91975</name>
      <address>
        <city>Fergana</city>
        <zip>150100</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91986</name>
      <address>
        <city>Samarkand</city>
        <zip>140108</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 100616</name>
      <address>
        <city>Tashkent</city>
        <zip>100007</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91984</name>
      <address>
        <city>Tashkent</city>
        <zip>100029</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91977</name>
      <address>
        <city>Tashkent</city>
        <zip>100069</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91981</name>
      <address>
        <city>Tashkent</city>
        <zip>100093</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91982</name>
      <address>
        <city>Tashkent</city>
        <zip>100093</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 92473</name>
      <address>
        <city>Tashkent</city>
        <zip>100093</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91988</name>
      <address>
        <city>Tashkent</city>
        <zip>100109</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 92474</name>
      <address>
        <city>Tashkent</city>
        <zip>100171</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91976</name>
      <address>
        <city>Tashkent</city>
        <zip>100206</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91983</name>
      <address>
        <city>Tashkent</city>
        <zip>100206</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91980</name>
      <address>
        <city>Urgench</city>
        <zip>220100</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 91985</name>
      <address>
        <city>Urgench</city>
        <zip>220100</zip>
        <country>Uzbekistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kazakhstan</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>Uzbekistan</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>June 9, 2015</results_first_submitted>
  <results_first_submitted_qc>September 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 30, 2015</results_first_posted>
  <last_update_submitted>November 23, 2015</last_update_submitted>
  <last_update_submitted_qc>November 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dydrogesterone</keyword>
  <keyword>Irregular Menstrual Cycle</keyword>
  <keyword>Progestins</keyword>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 1000 patients were screened. 1 Patient failed screening and 999 were enrolled into the program.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
          <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="999"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="782"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="217"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>variety of other minor reasons</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>no reason specified</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles</population>
      <group_list>
        <group group_id="B1">
          <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
          <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="955"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.3" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="955"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uzbekistan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Kazakhstan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period</title>
        <description>Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles</description>
        <time_frame>Up to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period</title>
          <description>Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="955"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea</title>
        <description>Polymenorrhea was defined as cycle duration &lt; 21 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea</title>
          <description>Polymenorrhea was defined as cycle duration &lt; 21 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea</title>
        <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea</title>
          <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the change in duration of the menstrual cycle during treatment was evaluated</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="711"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.7" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea</title>
        <description>Polymenorrhea is defined as cycle duration &lt; 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea</title>
          <description>Polymenorrhea is defined as cycle duration &lt; 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea</title>
        <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea</title>
          <description>Oligomenorrhea is defined as cycle duration &gt; 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="721"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Pain Intensity During Menstruation From Baseline to End of Treatment</title>
        <description>Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Pain Intensity During Menstruation From Baseline to End of Treatment</title>
          <description>Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="916"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Intensity of Anxiety From Baseline to the End of Treatment</title>
        <description>Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
        <time_frame>From 1 month to 6 months</time_frame>
        <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Intensity of Anxiety From Baseline to the End of Treatment</title>
          <description>Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
          <population>Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="904"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With the Treatment</title>
        <description>Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With the Treatment</title>
          <description>Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.</description>
          <population>Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="919"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>somewhat satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>very dissatisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Clinical Response on Treatment Assessed by Physician</title>
        <description>Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Clinical Response on Treatment Assessed by Physician</title>
          <description>Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.</description>
          <population>Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="919"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</title>
        <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
        <time_frame>Up to 9 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</title>
          <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</title>
        <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
        <time_frame>Up to 12 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period</title>
          <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea</title>
        <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration &lt; 21 days</description>
        <time_frame>From 1 month to 12 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea</title>
          <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration &lt; 21 days</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea</title>
        <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration &gt; 35 days</description>
        <time_frame>From 1 month to 12 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea</title>
          <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration &gt; 35 days</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="651"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Pain Intensity During Menstruation</title>
        <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
        <time_frame>From 1 month to 12 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Pain Intensity During Menstruation</title>
          <description>Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Intensity of Anxiety</title>
        <description>Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
        <time_frame>From 1 month to 12 months</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Intensity of Anxiety</title>
          <description>Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)</title>
        <time_frame>up to 6 months</time_frame>
        <population>Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)</title>
          <population>Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 therapy cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 therapy cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 therapy cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 therapy cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 therapy cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 therapy cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)</title>
        <time_frame>up to 6 months</time_frame>
        <population>Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)</title>
          <population>Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 regular cycle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="545"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 regular cycles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3181</p_value>
            <p_value_desc>Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.</p_value_desc>
            <method>Mantel Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Relapse</title>
        <description>The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.</description>
        <time_frame>Up to 6 months or longer after ended treatment</time_frame>
        <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.&#xD;
Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (&gt;85%) maintained regular cycles for the whole follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
            <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Relapse</title>
          <description>The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.</description>
          <population>Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.&#xD;
Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (&gt;85%) maintained regular cycles for the whole follow-up period</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="860"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Safety was monitored by recording of serious adverse events (SAEs) and pregnancies and spontaneously reported adverse events (AEs) from signed informed consent up to 30 days after the final dose of dydrogesterone.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Women Received Dydrogesterone for Irregular Menstrual Cycle</title>
          <description>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion missed</sub_title>
                <description>no reasonable possibility of a relationship to the program drug.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <description>no reasonable possibility of a relationship to the program drug.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <description>The most commonly reported preferred term</description>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="986"/>
              </event>
              <event>
                <sub_title>Uternine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="986"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Investigator shall not publish/present the results without Abbott's prior written consent. In the event that applicable law permits Investigator to publish or present results without Abbott's prior written consent, Investigator shall provide Abbott with a complete copy of such publication or presentation at least 60 days prior to submission for publication or presentation and Investigator shall reasonably consider all comments which Abbott may provide regarding such publication or presentation</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Follow up period was limited to 6 months of observation. Pregnancy incidence was not the aim of research, however, spontaneous pregnancies were observed in 56 (5.6%) patients following standard dosages of dydrogesterone for irregular cycle treatment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Global Medical Director</name_or_title>
      <organization>Abbott</organization>
      <phone>+49 160 749 0615</phone>
      <email>Claire.Pexman-Fieth@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711216
org study id: P13-688
nct id: NCT01711216
lead sponsor: 
has dmc: No
Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan
      and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for
      management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,
      dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,
      infertility due to luteal insufficiency, as well as part of hormone replacement therapy.
      There are limited data regarding dydrogesterone's role in achieving cycle regularization from
      post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in
      a post-marketing setting after cessation of treatment and whether the persistence, if any, is
      related to the duration of dydrogesterone therapy. Hence, in this observational program, the
      goal is to observe the possible implications of such treatment in terms of treatment length
      and response pattern.
The program is designed as a prospective, multicentre, observational, non-interventional,
      non-randomized, non-controlled, single arm, post-marketing program. Being an observational
      program, the assignment of patients to dydrogesterone therapy will not be decided with an
      intention to include patients in the program, but will be guided as per standard clinical
      practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly
      separate from the decision to include patients in this program. All dydrogesterone
      prescriptions will be made in accordance with locally approved package insert for
      dydrogesterone.
time perspective: Prospective
measure: Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
time frame: up to 6 months
measure: Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
time frame: up to 6 months
measure: Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
time frame: Up to 6 months
description: Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles
measure: Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea
time frame: From 1 month to 6 months
description: Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated
measure: Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea
time frame: From 1 month to 6 months
description: Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated
measure: Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
time frame: From 1 month to 6 months
description: Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
measure: Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea
time frame: From 1 month to 6 months
description: Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days
measure: Change of Pain Intensity During Menstruation From Baseline to End of Treatment
time frame: From 1 month to 6 months
description: Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain
measure: Change of Intensity of Anxiety From Baseline to the End of Treatment
time frame: From 1 month to 6 months
description: Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety
measure: Patient Satisfaction With the Treatment
time frame: Up to 6 months
description: Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.
measure: Overall Clinical Response on Treatment Assessed by Physician
time frame: Up to 6 months
description: Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.
measure: Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period
time frame: Up to 9 months
description: Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive
measure: Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period
time frame: Up to 12 months
description: Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive
measure: Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
time frame: From 1 month to 12 months
description: Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days
measure: Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea
time frame: From 1 month to 12 months
description: Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days
measure: Change of Pain Intensity During Menstruation
time frame: From 1 month to 12 months
description: Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain
measure: Change of Intensity of Anxiety
time frame: From 1 month to 12 months
description: Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety
measure: Time to Relapse
time frame: Up to 6 months or longer after ended treatment
description: The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.
arm group label: women received dydrogesterone for irregular menstrual cycle
description: Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Claire Pexman-Fieth, MD
role: Study Director
affiliation: Abbott
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country: Kazakhstan
country: Russian Federation
country: Ukraine
country: Uzbekistan
responsible party type: Sponsor
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Follow up period was limited to 6 months of observation. Pregnancy incidence was not the aim of research, however, spontaneous pregnancies were observed in 56 (5.6%) patients following standard dosages of dydrogesterone for irregular cycle treatment.
point of contact: 