Status:
COMPLETED
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Endometriosis
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment i...
Detailed Description
This is a prospective, randomized, double-blind study. Subjects who have completed the 6-month Treatment Period in 18-OBE2109-003 - Edelweiss 3 study (herein referred to as main study) will be invited...
Eligibility Criteria
Inclusion
- The subject must have:
- completed the 6-month treatment in the main study.
- agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
- To continue to comply with the requirements of the study protocol for the duration of the extension study.
Exclusion
- The subject will be excluded if she:
- Is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the Follow-up Period).
- likely to require treatment during the study with any of the restricted medications
- has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (TVUS), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives.
- met any of the main study discontinuation criteria
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT04335591
Start Date
March 5 2020
End Date
December 15 2022
Last Update
April 2 2025
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
Choice Research, LLC/ ID # 609
Dothan, Alabama, United States, 36303
2
Universal Axon - Homestead, LLC/ ID # 620
Homestead, Florida, United States, 33030
3
Stedman Clinical Trials/ ID # 612
Tampa, Florida, United States, 33613
4
Advanced Specialty Research/ ID # 610
Nampa, Idaho, United States, 83687