xml: <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/NCT05976529</url>
    </required_header>
    <id_info>
      <org_study_id>GuangdongWCH-LiLi02</org_study_id>
      <nct_id>NCT05976529</nct_id>
    </id_info>
    <brief_title>A Multicenter, Observational Clinical Study of Dydrogesterone</brief_title>
    <official_title>Efficacy and Safety of Dydrogesterone After Operation of Ovarian Endometrial Cysts: a Multicenter, Observational Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangdong Women and Children Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangdong Women and Children Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study was to investigate the efficacy and safety of dydrogesterone in&#xD;
        the long-term management of ovarian endometriosis cyst after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Endometriosis refers to the appearance, growth and infiltration of endometrial tissue (glands&#xD;
        and stroma) in the lining of the uterine cavity and other parts of the uterus, and repeated&#xD;
        bleeding, which causes pain, infertility and nodules or masses. Endometriosis is a common&#xD;
        gynecological disease in Chinese female patients, and its incidence has been increasing in&#xD;
        recent years, which seriously affects the fertility and quality of life of patients. The&#xD;
        typical clinical manifestations of endometriosis mainly include dysmenorrhea, pelvic pain and&#xD;
        dyspareunia. Dysmenorrhea is a common symptom of endometriosis, which is secondary and&#xD;
        persistent. The pain is most severe on the first day of menstruation and disappears&#xD;
        completely at the end of menstruation. Pain is mainly caused by endometriosis bleeding, which&#xD;
        irritates the inflammatory response of local tissues. Endometriosis lesions secrete&#xD;
        prostaglandins, which cause contracture of uterine muscles and aggravate dysmenorrhea.&#xD;
        Ovarian endometriotic cysts are the most common and easily detected type of endometriosis.&#xD;
        Its clinical manifestations include: 1) dysmenorrhea, affecting daily activities and life; 2)&#xD;
        chronic pelvic pain; 3) pain during or after sexual intercourse; 4) often complicated with&#xD;
        infertility; 5) ovarian endometriotic cyst formation by imaging examination; 6) elevated&#xD;
        CA125.&#xD;
  &#xD;
        According to the guidelines for the diagnosis and treatment of endometriosis (third edition)&#xD;
        published by Chinese Journal of Obstetrics and Gynecology in December 2021, ovarian&#xD;
        endometriosis cysts can be divided into medical treatment and surgical treatment. The&#xD;
        indications for drug therapy were: 1) ovarian endometriosis cyst diameter &lt;4cm; 2) have&#xD;
        pelvic pain. The treatment drugs include oral contraceptives, progesterone analogues,&#xD;
        gestrinone, gonadotropin-releasing hormone agonist (GnRHa) and traditional Chinese medicine.&#xD;
        The indications for surgical treatment were: 1) the diameter of ovarian endometriosis cyst&#xD;
        ≥4cm; 2) combined infertility; 3) pain medications are ineffective. In clinical practice,&#xD;
        most patients lose the opportunity of drug treatment, or drug treatment is ineffective, and&#xD;
        most patients need surgical treatment. Laparoscopic surgery is the first choice for surgical&#xD;
        treatment, and cystectomy is recommended. However, surgical treatment can only remove the&#xD;
        superficial lesions, and it is difficult to remove the deep lesions, which is easy to leave&#xD;
        lesions. After surgery, affected by steroid hormones, the small lesions left are easy to&#xD;
        relapse, leading to the characteristics of recurrent disease. Therefore, the recurrence rate&#xD;
        of ovarian endometriosis cyst after conservative surgery is high, and it must be treated with&#xD;
        drugs and long-term management after surgery.&#xD;
  &#xD;
        In the postoperative drug management of ovarian endometriosis cyst, the first-line drugs are&#xD;
        mainly progesterone analogues (dienogest), GnRH-a, dydrogesterone and so on. There is&#xD;
        evidence that the continuous use of dienogest for 24 months after surgery can significantly&#xD;
        reduce the recurrence rate of ovarian endometriosis cysts. Dienogest is a fourth-generation&#xD;
        highly selective progesterone receptor agonist, which acts locally on endometriotic lesions,&#xD;
        has no male, estrogen, glucose and mineralocorticoid activity, and does not affect&#xD;
        metabolism. It is used in the first-line treatment of endometriosis. &quot;In a German&#xD;
        retrospective study, dienogest 2 mg daily for 60 months was effective in reducing&#xD;
        endometriosis associated pelvic pain, and dienogest was well tolerated.&quot; However, ovulation&#xD;
        was inhibited in most patients during dienogest treatment. For patients with fertility needs,&#xD;
        menstruation returned to normal after stopping dienogest for 2 months. To pregnant element is&#xD;
        the most common adverse drug reactions: frequent or long time of uterine bleeding (3.2%),&#xD;
        insomnia (2.7%), acne (2.1%), nausea (2.1%), weight (2.1%), lower abdominal discomfort&#xD;
        (1.6%), headache (1.6%), breast discomfort (1.1%), and depressed mood (1.1%). Therefore, it&#xD;
        is not suitable to use dienogest for postoperative management in patients with ovarian&#xD;
        endometriosis who are in urgent need of pregnancy after surgery. At present, the cost of&#xD;
        dienogest in our country is relatively high, about 500 yuan for a box (28 tablets), and there&#xD;
        will be a certain economic burden for ordinary patients.&#xD;
  &#xD;
        &quot;Dydrogesterone is similar in structure to conventional progesterone and has only progestogen&#xD;
        activity without estrogen, androgen, or mineralocorticoid activity. It atrophies the ectopic&#xD;
        endometrium, prevents the development of new endometriotic lesions, and does not inhibit&#xD;
        normal endometrium or ovulation. The menstrual cycle is regular in the course of regular&#xD;
        treatment with dydrogesterone, so normal pregnancy can be achieved during the treatment.&quot; An&#xD;
        open, multi-center, post-marketing, observational clinical study in Japan showed that&#xD;
        dydrogesterone could effectively inhibit the growth of ovarian endometriosis cysts and&#xD;
        improve the total score of dysmenorrhea and the degree of dysmenorrhea pain. Studies have&#xD;
        shown that long-term treatment of endometriosis with dydrogesterone after surgery for 12&#xD;
        months can significantly reduce endometriosis-associated pain, treat infertility, and prevent&#xD;
        recurrence of the disease. A Japanese multi-center study showed that the incidence of adverse&#xD;
        drug reactions of dydrogesterone was 31.8%, and the most common adverse event was uterine&#xD;
        bleeding. Dydrogesterone endometriosis was effective, safe and clinically beneficial for&#xD;
        patients. For patients in urgent need of pregnancy, natural pregnancy can still be achieved&#xD;
        during postoperative medication.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analogue pain score(VAS)</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>The visual analogue scale (VAS) was used to evaluate the pain. It is widely used in clinical practice in China. The basic method is to use a swimming ruler of about 10cm in length, marked with 10 scales on one side, and &quot;0&quot; and &quot;10&quot; points on both ends, with 0 points indicating no pain and 10 points indicating the most severe pain that can be endured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Endometriosis fertility index(EFI)</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>EFI score of endometriosis refers to the evaluation of fertility in patients with normal semen in men and good ovarian reserve function in women without adenomyosis. The pregnancy rate was measured by quantifying the patient's age, the duration and type of infertility, and the function of the fallopian tubes, uterus, and ovaries. If the score is higher than 9, the patient can try natural pregnancy. If the score is 5-8 points, the patient can be monitored by fertility guidance, if not naturally pregnant, can be treated by IVF-ET. If the score is lower than 5 points, the patients can be directly treated by IVF-ET.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Cox Menstrual Symptom Scale(CMSS)</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>The Cox menstrual symptom scale (CMSS) was used to evaluate the severity of symptoms and the duration of dysmenorrhea. The scale included 2 parts, CMSS-severity (CMSS-S) and CMSS-duration (CMSS-T), with a total of 18 observation indicators. It included 17 symptoms including nausea, vomiting, loss of appetite, headache, vertigo and the duration of dysmenorrhea. All CMSS-S items were scored on a 5-point scale: 0 as no symptoms, 1 as mild, 2 as moderate, 3 as severe, and 4 as extremely severe. CMSS-T is also a 5-point scale: 0 for no symptoms, 1 for persistent &amp;lt; 3h, 2 for 3~7h, 3 for 7~24h, 4 for continuous &amp;gt; 24 hours.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum CA125</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>In some infectious diseases, autoimmune diseases, gynecological benign diseases, malignant tumors can appear CA125 significantly increased.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-mullerian hormone(AMH)</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>AMH is an important index to evaluate AMH is an important index to evaluate the reserve function of ovarian.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short form 36（SF36）</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>The SF36 is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). There is a further unscaled single item on changes in respondents' health over the past year. For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The postoperative pregnancy of the patients.</measure>
      <time_frame>3 months after drug treatment</time_frame>
      <description>Patients were followed up by phone calls to find out whether they were pregnant.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Liver function</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>Liver function is used to assess the safety level of dydrogesterone and dienogest. Liver function includes the level of ALT, AST, ALT/AST by blood test.</description>
    </other_outcome>
    <other_outcome>
      <measure>Kidney function</measure>
      <time_frame>before drug treatment and 3 months after drug treatment</time_frame>
      <description>Kidney function is used to assess the safety level of dydrogesterone and dienogest. Kidney function includes the level of Urea, CO2, CRE, UA, β2-MG by blood test.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Endometriosis</condition>
    <condition>Endometriosis Ovary</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <description>From the 5th to 25th day of menstrual cycle, 10 mg dydrogesterone was taken orally twice a day for 3 menstrual cycles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>After postoperative pathological diagnosis, oral dienogest was started, 4 weeks as a course of treatment, and 3 courses of continuous treatment were given.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged 18-45 years after surgery for ovarian endometriosis cyst&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who had undergone laparoscopic ovarian cyst excision and were confirmed by&#xD;
               pathological diagnosis as ovarian endometriosis cyst (pathology was completed in each&#xD;
               central hospital).&#xD;
  &#xD;
            -  Ovarian cyst &gt;4cm.&#xD;
  &#xD;
            -  Concomitant infertility.&#xD;
  &#xD;
            -  Patients who fail to respond to medication.&#xD;
  &#xD;
            -  American Society of Reproductive Medicine(ASRM) stages were II-IV.&#xD;
  &#xD;
            -  No relevant therapeutic drugs, such as dydrogesterone, dienogest, GnRHa, etc., were&#xD;
               used 3 months before treatment.&#xD;
  &#xD;
            -  No combined endocrine diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ovulation disorders, immune defects and genital development abnormalities caused by&#xD;
               infertility.&#xD;
  &#xD;
            -  Patients who are allergic to the drugs used in this study.&#xD;
  &#xD;
            -  Patients with severe hepatorenal insufficiency or malignant tumor.&#xD;
  &#xD;
            -  Those who took hormone medication within 3 months before the study date.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Chen Yuan, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guangdong Women and Children Hosptial</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Li, M.D.</last_name>
      <phone>+86 13631446859</phone>
      <email>lili-1406@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Guangdong Women and Children Hospital</name>
        <address>
          <city>Guanzhou</city>
          <state>Guangdong</state>
          <zip>511400</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Li, M.D.</last_name>
        <phone>+8613631446859</phone>
        <email>lili-1406@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Guangdong Women and Children Hospital</investigator_affiliation>
      <investigator_full_name>Li Li</investigator_full_name>
      <investigator_title>Deputy Director, Institute of Women's and Children's Health</investigator_title>
    </responsible_party>
    <keyword>endometriosis</keyword>
    <keyword>dydrogesterone</keyword>
    <keyword>therapeutic effect evaluation</keyword>
    <keyword>safety</keyword>
    <keyword>dienogest</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometriosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976529
  org study id: GuangdongWCH-LiLi02
  nct id: NCT05976529
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study was to investigate the efficacy and safety of dydrogesterone in
        the long-term management of ovarian endometriosis cyst after surgery.
  Endometriosis refers to the appearance, growth and infiltration of endometrial tissue (glands
        and stroma) in the lining of the uterine cavity and other parts of the uterus, and repeated
        bleeding, which causes pain, infertility and nodules or masses. Endometriosis is a common
        gynecological disease in Chinese female patients, and its incidence has been increasing in
        recent years, which seriously affects the fertility and quality of life of patients. The
        typical clinical manifestations of endometriosis mainly include dysmenorrhea, pelvic pain and
        dyspareunia. Dysmenorrhea is a common symptom of endometriosis, which is secondary and
        persistent. The pain is most severe on the first day of menstruation and disappears
        completely at the end of menstruation. Pain is mainly caused by endometriosis bleeding, which
        irritates the inflammatory response of local tissues. Endometriosis lesions secrete
        prostaglandins, which cause contracture of uterine muscles and aggravate dysmenorrhea.
        Ovarian endometriotic cysts are the most common and easily detected type of endometriosis.
        Its clinical manifestations include: 1) dysmenorrhea, affecting daily activities and life; 2)
        chronic pelvic pain; 3) pain during or after sexual intercourse; 4) often complicated with
        infertility; 5) ovarian endometriotic cyst formation by imaging examination; 6) elevated
        CA125.
  
        According to the guidelines for the diagnosis and treatment of endometriosis (third edition)
        published by Chinese Journal of Obstetrics and Gynecology in December 2021, ovarian
        endometriosis cysts can be divided into medical treatment and surgical treatment. The
        indications for drug therapy were: 1) ovarian endometriosis cyst diameter <4cm; 2) have
        pelvic pain. The treatment drugs include oral contraceptives, progesterone analogues,
        gestrinone, gonadotropin-releasing hormone agonist (GnRHa) and traditional Chinese medicine.
        The indications for surgical treatment were: 1) the diameter of ovarian endometriosis cyst
        ≥4cm; 2) combined infertility; 3) pain medications are ineffective. In clinical practice,
        most patients lose the opportunity of drug treatment, or drug treatment is ineffective, and
        most patients need surgical treatment. Laparoscopic surgery is the first choice for surgical
        treatment, and cystectomy is recommended. However, surgical treatment can only remove the
        superficial lesions, and it is difficult to remove the deep lesions, which is easy to leave
        lesions. After surgery, affected by steroid hormones, the small lesions left are easy to
        relapse, leading to the characteristics of recurrent disease. Therefore, the recurrence rate
        of ovarian endometriosis cyst after conservative surgery is high, and it must be treated with
        drugs and long-term management after surgery.
  
        In the postoperative drug management of ovarian endometriosis cyst, the first-line drugs are
        mainly progesterone analogues (dienogest), GnRH-a, dydrogesterone and so on. There is
        evidence that the continuous use of dienogest for 24 months after surgery can significantly
        reduce the recurrence rate of ovarian endometriosis cysts. Dienogest is a fourth-generation
        highly selective progesterone receptor agonist, which acts locally on endometriotic lesions,
        has no male, estrogen, glucose and mineralocorticoid activity, and does not affect
        metabolism. It is used in the first-line treatment of endometriosis. "In a German
        retrospective study, dienogest 2 mg daily for 60 months was effective in reducing
        endometriosis associated pelvic pain, and dienogest was well tolerated." However, ovulation
        was inhibited in most patients during dienogest treatment. For patients with fertility needs,
        menstruation returned to normal after stopping dienogest for 2 months. To pregnant element is
        the most common adverse drug reactions: frequent or long time of uterine bleeding (3.2%),
        insomnia (2.7%), acne (2.1%), nausea (2.1%), weight (2.1%), lower abdominal discomfort
        (1.6%), headache (1.6%), breast discomfort (1.1%), and depressed mood (1.1%). Therefore, it
        is not suitable to use dienogest for postoperative management in patients with ovarian
        endometriosis who are in urgent need of pregnancy after surgery. At present, the cost of
        dienogest in our country is relatively high, about 500 yuan for a box (28 tablets), and there
        will be a certain economic burden for ordinary patients.
  
        "Dydrogesterone is similar in structure to conventional progesterone and has only progestogen
        activity without estrogen, androgen, or mineralocorticoid activity. It atrophies the ectopic
        endometrium, prevents the development of new endometriotic lesions, and does not inhibit
        normal endometrium or ovulation. The menstrual cycle is regular in the course of regular
        treatment with dydrogesterone, so normal pregnancy can be achieved during the treatment." An
        open, multi-center, post-marketing, observational clinical study in Japan showed that
        dydrogesterone could effectively inhibit the growth of ovarian endometriosis cysts and
        improve the total score of dysmenorrhea and the degree of dysmenorrhea pain. Studies have
        shown that long-term treatment of endometriosis with dydrogesterone after surgery for 12
        months can significantly reduce endometriosis-associated pain, treat infertility, and prevent
        recurrence of the disease. A Japanese multi-center study showed that the incidence of adverse
        drug reactions of dydrogesterone was 31.8%, and the most common adverse event was uterine
        bleeding. Dydrogesterone endometriosis was effective, safe and clinically beneficial for
        patients. For patients in urgent need of pregnancy, natural pregnancy can still be achieved
        during postoperative medication.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Visual analogue pain score(VAS)
  time frame: before drug treatment and 3 months after drug treatment
  description: The visual analogue scale (VAS) was used to evaluate the pain. It is widely used in clinical practice in China. The basic method is to use a swimming ruler of about 10cm in length, marked with 10 scales on one side, and "0" and "10" points on both ends, with 0 points indicating no pain and 10 points indicating the most severe pain that can be endured.
  measure: Endometriosis fertility index(EFI)
  time frame: before drug treatment and 3 months after drug treatment
  description: EFI score of endometriosis refers to the evaluation of fertility in patients with normal semen in men and good ovarian reserve function in women without adenomyosis. The pregnancy rate was measured by quantifying the patient's age, the duration and type of infertility, and the function of the fallopian tubes, uterus, and ovaries. If the score is higher than 9, the patient can try natural pregnancy. If the score is 5-8 points, the patient can be monitored by fertility guidance, if not naturally pregnant, can be treated by IVF-ET. If the score is lower than 5 points, the patients can be directly treated by IVF-ET.
  measure: The Cox Menstrual Symptom Scale(CMSS)
  time frame: before drug treatment and 3 months after drug treatment
  description: The Cox menstrual symptom scale (CMSS) was used to evaluate the severity of symptoms and the duration of dysmenorrhea. The scale included 2 parts, CMSS-severity (CMSS-S) and CMSS-duration (CMSS-T), with a total of 18 observation indicators. It included 17 symptoms including nausea, vomiting, loss of appetite, headache, vertigo and the duration of dysmenorrhea. All CMSS-S items were scored on a 5-point scale: 0 as no symptoms, 1 as mild, 2 as moderate, 3 as severe, and 4 as extremely severe. CMSS-T is also a 5-point scale: 0 for no symptoms, 1 for persistent &lt; 3h, 2 for 3~7h, 3 for 7~24h, 4 for continuous &gt; 24 hours.
  measure: Serum CA125
  time frame: before drug treatment and 3 months after drug treatment
  description: In some infectious diseases, autoimmune diseases, gynecological benign diseases, malignant tumors can appear CA125 significantly increased.
  measure: Anti-mullerian hormone(AMH)
  time frame: before drug treatment and 3 months after drug treatment
  description: AMH is an important index to evaluate AMH is an important index to evaluate the reserve function of ovarian.
  measure: Short form 36（SF36）
  time frame: before drug treatment and 3 months after drug treatment
  description: The SF36 is a short questionnaire with 36 items which measure eight multi-item variables: physical functioning (10 items), social functioning (two items), role limitations due to physical problems (four items), role limitations due to emotional problems (three items), mental health (five items), energy and vitality (four items), pain (two items), and general perception of health (five items). There is a further unscaled single item on changes in respondents' health over the past year. For each variable item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state).
  measure: The postoperative pregnancy of the patients.
  time frame: 3 months after drug treatment
  description: Patients were followed up by phone calls to find out whether they were pregnant.
  measure: Liver function
  time frame: before drug treatment and 3 months after drug treatment
  description: Liver function is used to assess the safety level of dydrogesterone and dienogest. Liver function includes the level of ALT, AST, ALT/AST by blood test.
  measure: Kidney function
  time frame: before drug treatment and 3 months after drug treatment
  description: Kidney function is used to assess the safety level of dydrogesterone and dienogest. Kidney function includes the level of Urea, CO2, CRE, UA, β2-MG by blood test.
  arm group label: study group
  description: From the 5th to 25th day of menstrual cycle, 10 mg dydrogesterone was taken orally twice a day for 3 menstrual cycles.
  arm group label: control group
  description: After postoperative pathological diagnosis, oral dienogest was started, 4 weeks as a course of treatment, and 3 courses of continuous treatment were given.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 45 Years
  last name: Chen Yuan, Master
  role: Principal Investigator
  affiliation: Guangdong Women and Children Hosptial
  last name: Li Li, M.D.
  phone: +86 13631446859
  email: lili-1406@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Guangdong Women and Children Hospital
  investigator full name: Li Li
  investigator title: Deputy Director, Institute of Women's and Children's Health
  mesh term: Endometriosis