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Study Type :. Assessed by an Adverse Events Log completed by the Investigator.
Score ranges from with lower score denoting improvement. Estimated Primary Completion Date :. Undiagnosed abnormal vaginal bleeding.
History of no relief of endometriosis related pain after any medical therapy or surgery. Changes in the Endometriosis Health Profile EHP scores [ Time Frame: From baseline to menstrual cycle 4 around 4 months, each cycle is approximately 28 days ] Assessed by the EHP quality-of-life questionnaire completed by subjects. Frequency of avoiding sexual intercourse due to expected pain [ Time Frame: From baseline to menstrual cycle 4 around 4 months, each cycle is approximately 28 days ] Assessed daily by participants in an e-Diary Changes in the mean daily scores for the worst impact of endometriosis-related pain on the subject's ability to function.
Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound. Endometriosis-related Pain. Assessed by the PGIC scale completed by participants.
Actual Study Start Date :. DK0-Disclosure ferring. Arms and Interventions. For general information, Learn About Clinical Studies. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Exclusion Criteria: Use of depot medroxyprogesterone acetate MPA within 10 months of the start of run-in. Save this study.
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Assessed by the EHP quality-of-life questionnaire completed by subjects. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
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EHP is a quality-of-life questionnaire. Search for terms x. Read our disclaimer for details. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Assessed weekly by participants in an e-Diary. NRS is a point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Assessed daily by participants in an e-Diary. Having moderate to severe endometriosis-related pain.
Outcome Measures. Phase 2. Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within 1 month of the start of run-in. Willing to use a non-hormonal barrier method i. Study record managers: refer to the Data Element Definitions if submitting registration or information. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Assessed by urine sample collection dip-stick test.
Changes in the mean daily Numerical Rating Scale NRS scores for the worst dyspareunia on days with sexual intercourse. Transvaginal ultrasound documenting a uterus with no clinically ificant abnormalities and presence of at least one ovary with no clinically ificant abnormalities with the exception of endometrioma at the run-in visit. Placebo Comparator: Placebo Vaginal ring containing matching placebo.
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain. Last Update Posted : May 4, See Contacts and Locations. Use of gonadotropin releasing hormone GnRH agonists 3 months depot or dopamine agonists within 6 months of the start of run-in. Assessed by the questionnaire for impulsive-compulsive disorders completed by subjects. Score ranges from and lower score denotes improvement. Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices from randomization to the end of treatment.
Known bone diseases e. Study Description. Eligibility Criteria. Interventional Clinical Trial.
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This is not required if adequate contraception is achieved by vasectomy of the sexual partner or surgical sterilisation of the subject. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad". More Information. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services.
Charleston, South Carolina, United States, October 2, Key Record Dates. Springfield, Illinois, United States, Fayetteville, North Carolina, United States, Hillsborough, North Carolina, United States, Penn State Health - Milton S. Hershey Medical Center.
Drug: Placebo Matching placebo. PGIS is a 6-point scale depicting a subject's rating of their current conditions from "good" to "bad". Talk with your doctor and family members or friends about deciding to a study. MedQueriesUS ferring.
Estimated Enrollment :. Assessed by the PGIS scale completed by participants.
Please refer to this study by its ClinicalTrials. FDA Resources. Willing to change usual analgesics to rescue analgesics as permitted by protocol for endometriosis-related pain from the start of run-in to the end-of-trial. Any ificant abnormal findings of heart examinations before randomization.
Plasma concentration of quinagolide and metabolites [ Time Frame: Within 5 days after first ring insertion and at around 1 month, 3 months, 3. Secondary Outcome Measures : Changes in the mean daily Numerical Rating Scale NRS scores for the worst endometriosis-related pain on days with menstrual bleeding and for the worst endometriosis-related pain on days with no menstrual bleeding [ Time Frame: At baseline and at menstrual cycle 4 around 4 months, each cycle is approximately 28 days ] Assessed daily by participants in an e-Diary.
Use of GnRH agonists 1 month depot or intrauterine device within 3 months of the start of run-in.
Changes in vaginal bleeding pattern. However, history of partial pain relief, discontinuation due to side effects are not exclusionary. Estimated Study Completion Date :.