Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

• Status: Enrolling by invitation
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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 in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA

Criteria

Inclusion Criteria:

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 Criteria:

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