<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/NCT03034057</url>
  </required_header>
  <id_info>
    <org_study_id>A6791040</org_study_id>
    <secondary_id>2017-000051-13</secondary_id>
    <nct_id>NCT03034057</nct_id>
  </id_info>
  <brief_title>Sayana Press UK Self-Injection Study</brief_title>
  <official_title>PHASE IV OPEN LABEL SINGLE GROUP ONE YEAR STUDY OF HOME SELF-INJECTION WITH SAYANA (REGISTERED) PRESS IN ADULT WOMEN OF REPRODUCTIVE AGE - A PRAGMATIC CLINICAL TRIAL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A one-year evaluation of Sayana Press self injection in women of reproductive age in the&#xD;
      United Kingdom (UK).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">December 7, 2018</completion_date>
  <primary_completion_date type="Actual">December 7, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year</measure>
    <time_frame>1 year</time_frame>
    <description>Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Contraception</condition>
  <arm_group>
    <arm_group_label>sayana press</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sayana Press</intervention_name>
    <description>Sayana Press in the Uniject injection system</description>
    <arm_group_label>sayana press</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women aged 18 to 45 years of age who are willing to attempt Sayana Press&#xD;
             self-injection at home;&#xD;
&#xD;
          -  women who are likely to be successful on a DMPA self-injection program, based on the&#xD;
             opinion of the investigator;&#xD;
&#xD;
          -  not planning to move out of the area for at least 12 months;&#xD;
&#xD;
          -  willing to be contacted by the clinical staff at work or at home;&#xD;
&#xD;
          -  evidence of a personally signed and dated Informed Consent Document (ICD) indicating&#xD;
             that the subject has been informed of all pertinent aspects of the study;&#xD;
&#xD;
          -  subjects who are willing and able to comply with scheduled visits, treatment plan and&#xD;
             other study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a pre-existing medical condition that would interfere with participation in the study&#xD;
             or pose a risk to the subject, including hypersensitivity to MPA or any constituents&#xD;
             of Sayana Press;&#xD;
&#xD;
          -  known or suspected malignancy of genital organs;&#xD;
&#xD;
          -  known or suspected malignancy of the breast;&#xD;
&#xD;
          -  history of cerebrovascular disease&#xD;
&#xD;
          -  metabolic bone disease&#xD;
&#xD;
          -  a contraindication to DMPA (UK Medical Eligibility Criteria Category 3 or 4) such as:&#xD;
&#xD;
          -  Multiple risk factors for cardiovascular disease (e.g. older age, smoking, diabetes,&#xD;
             obesity, hypertension)&#xD;
&#xD;
          -  current and history of ischaemic heart disease;&#xD;
&#xD;
          -  stroke (history of cerebrovascular accident, including transient ischaemic attack);&#xD;
&#xD;
          -  unexplained vaginal bleeding;&#xD;
&#xD;
          -  current or history of breast cancer;&#xD;
&#xD;
          -  diabetic nephropathy, neuropathy, retinopathy or other diabetic vascular disease;&#xD;
&#xD;
          -  severe (decompensated) liver cirrhosis;&#xD;
&#xD;
          -  hepatocellular adenoma;&#xD;
&#xD;
          -  hepatoma;&#xD;
&#xD;
          -  Systemic Lupus Erythematosus (positive or unknown antiphospholipid antibodies; severe&#xD;
             thrombocytopenia;&#xD;
&#xD;
          -  subjects who are investigational centre staff members directly involved in the conduct&#xD;
             of the study and their family members, centre staff members otherwise supervised by&#xD;
             the investigator, or subjects who are Pfizer employees involved in the conduct of the&#xD;
             study;&#xD;
&#xD;
          -  participation in other studies involving investigational drug(s) within 30 days prior&#xD;
             to study entry and/or during study participation;&#xD;
&#xD;
          -  patients who plan to get pregnant within two years of study;&#xD;
&#xD;
          -  breastfeeding and pregnant subjects;&#xD;
&#xD;
          -  other severe, acute, or chronic medical or psychiatric condition or laboratory&#xD;
             abnormality that may increase the risk associated with study participation or study&#xD;
             drug administration or may interfere with the interpretation of study results and, in&#xD;
             the judgement of the investigator, would make the subject inappropriate for entry into&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fowey Clinical Research Office</name>
      <address>
        <city>Fowey</city>
        <state>Cornwall</state>
        <zip>PL23 1DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fowey River Practice</name>
      <address>
        <city>Fowey</city>
        <state>Cornwall</state>
        <zip>PL23 1DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brannel Surgery</name>
      <address>
        <city>Saint Austell</city>
        <state>Cornwall</state>
        <zip>PL26 7RL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rame Medical Ltd, Penntorr Health</name>
      <address>
        <city>Torpoint</city>
        <state>Cornwall</state>
        <zip>PL11 2TB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rame Medical Ltd</name>
      <address>
        <city>Torpoint</city>
        <state>Cornwall</state>
        <zip>PL11 2TB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knowle House Surgery</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL5 3JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Ayrshire &amp; Arran, University Hospital Crosshouse</name>
      <address>
        <city>Kilmarnock</city>
        <state>EAST Ayrshire</state>
        <zip>KA2 0BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trafalgar Medical Group Practice</name>
      <address>
        <city>Southsea</city>
        <state>Hampshire</state>
        <zip>PO5 3ND</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Highland Clinical Research Facility</name>
      <address>
        <city>Inverness</city>
        <state>Highland</state>
        <zip>IV2 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent Community Health NHS Foundation Trust</name>
      <address>
        <city>Canterbury</city>
        <state>Kent</state>
        <zip>CT1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent Community Health NHS Foundation Trust</name>
      <address>
        <city>Chatham</city>
        <state>Kent</state>
        <zip>ME4 4DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southport &amp; Ormskirk Hospital NHS Trust, The May Logan Healthy Living Centre</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L205DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southport &amp; Ormskirk Hospital NHS Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L205DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian, Chalmers Sexual Health Centre</name>
      <address>
        <city>Edinburgh</city>
        <state>Midlothian</state>
        <zip>EH3 9ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Ayrshire &amp; Arran, Ayrshire Central Hospital</name>
      <address>
        <city>Irvine</city>
        <state>North Ayrshire</state>
        <zip>KA 12 8SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pickering Medical Practice</name>
      <address>
        <city>Pickering</city>
        <state>North Yorkshire</state>
        <zip>YO18 8BL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Chad's Surgery</name>
      <address>
        <city>Radstock</city>
        <state>Somerset</state>
        <zip>BA32UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <state>Tyne and Wear</state>
        <zip>NE1 6ND</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>WEST Midlands</state>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>WEST Midlands</state>
        <zip>B4 6DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eve Hill Medical Practice</name>
      <address>
        <city>Dudley</city>
        <state>WEST Midlands</state>
        <zip>DY1 2QD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford on Avon Health Centre</name>
      <address>
        <city>Bradford on Avon</city>
        <state>Wiltshire</state>
        <zip>BA15 1DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hathaway Medical Centre</name>
      <address>
        <city>Chippenham</city>
        <state>Wiltshire</state>
        <zip>SN14 6GT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trowbridge Health Centre</name>
      <address>
        <city>Trowbridge</city>
        <state>Wiltshire</state>
        <zip>BA148QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westbury Group Practice</name>
      <address>
        <city>Westbury</city>
        <state>Wiltshire</state>
        <zip>BA13 3FQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPS Research</name>
      <address>
        <city>Glasgow</city>
        <zip>G20 0XA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton University Hospital NHS Foundation Trust, Homerton</name>
      <address>
        <city>London</city>
        <zip>E9 6SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A6791040</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>September 23, 2019</results_first_submitted>
  <results_first_submitted_qc>September 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2019</results_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03034057/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03034057/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 169 adult women participants of reproductive age (18 to 45 years) were enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sayana Press</title>
          <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="169"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not defined</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Medication error without associated AE</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population included all participants who enrolled into the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Sayana Press</title>
          <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="169"/>
          </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="29.1" spread="7.26"/>
                  </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="169"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)</title>
        <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>The analysis population included participants who enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Sayana Press</title>
            <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)</title>
          <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.</description>
          <population>The analysis population included participants who enrolled into the study.</population>
          <units>Percentage of all attempts at home</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8" lower_limit="85.1" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)</title>
        <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>Sayana Press</title>
            <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)</title>
          <description>Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.</description>
          <population>The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.</population>
          <units>Percentage of all attempts at home</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3" lower_limit="85.6" upper_limit="92.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year</title>
        <description>Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.</description>
        <time_frame>1 year</time_frame>
        <population>The analysis population included participants who enrolled into the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Sayana Press</title>
            <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year</title>
          <description>Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.</description>
          <population>The analysis population included participants who enrolled into the study.</population>
          <units>Percentage of total participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.5" lower_limit="59.8" upper_limit="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 1 year</time_frame>
      <desc>The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Sayana Press</title>
          <description>Following product use education and a supervised initial self-injection at the baseline visit, participants self-injected Sayana Press in the home setting every 3 months (at Month 3, Month 6 and Month 9) and returned for a final study visit at Month 12.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Ovarian germ cell teratoma benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cauda equina syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA21.1</default_vocab>
        <default_assessment>Non-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="60" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Injection site mass</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="169"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="169"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="169"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT03034057
org study id: A6791040
secondary id: 2017-000051-13
nct id: NCT03034057
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A one-year evaluation of Sayana Press self injection in women of reproductive age in the
      United Kingdom (UK).
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)
time frame: Up to 1 year
description: Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.
measure: Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)
time frame: Up to 1 year
description: Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.
measure: Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year
time frame: 1 year
description: Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.
arm group label: sayana press
arm group type: Other
description: single arm
intervention type: Drug
intervention name: Sayana Press
description: Sayana Press in the Uniject injection system
arm group label: sayana press
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United Kingdom
url: https://pmiform.com/clinical-trial-info-request?StudyID=A6791040
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 