A double-blind randomized extension study to assess the long-term efficacy and safety of linzagolix in subjects with endometriosis-associated pain. - Edelweiss 3 extension
- Conditions
- Endometriosis-associated painMedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2019-002410-39-BG
- Lead Sponsor
- ObsEva S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 288
1. The subject must provide a written informed consent specific to this study prior to starting the extension study treatment.
2. The subject has completed the 6-month treatment in the main study.
3. The subject is willing and able to continue to comply with the requirements of the study protocol for the duration of the extension study.
4. The subject must agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
5. If of childbearing potential, the subject agrees to continue to use one of the permitted by the protocol birth control methods during the entire Treatment Period of the study and until 3 months after the end of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. The subject is pregnant or is planning a pregnancy within the duration of the study (including the Follow-up Period).
2. The subject is likely to require treatment during the study with any of the medications prohibited by the protocol.
3. The subject is likely to use cannabinoids during the study.
4. The subject has any other clinically significant gynecologic condition identified on TVUS or endometrial biopsy or at the manual breast examination during the main study, which might interfere with the study efficacy and safety objectives.
5. The subject has met any of the main study discontinuation criteria.
a. Serum calcium level confirmed on a repeat fasting test above 2.9 mmol/ L.
6.The subject has any condition that, in the opinion of the Investigator, constitutes a risk or a contraindication to the participation of the subject in this extension study or that could interfere with the study objectives, conduct or assessments.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method