Status:
TERMINATED
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
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-OBE2109-002 - Edelweiss 2 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
- agreed to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods
- agreed 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
- meets any of the main study discontinuation criteria
Key Trial Info
Start Date :
March 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04372121
Start Date
March 23 2020
End Date
February 16 2021
Last Update
April 2 2025
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Applied Res Center of Ar / Id # 735
Little Rock, Arkansas, United States, 72212
2
Futura Research, Inc. / ID # 781
Norwalk, California, United States, 90650
3
Adv Womens Health Institute / ID # 761
Greenwood Village, Colorado, United States, 80111
4
Red Rocks OB/GYN / ID # 732
Lakewood, Colorado, United States, 80228