Overview

Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ObsEva SA
Criteria
Inclusion Criteria:

The subject must have:

- Her most recent surgical and - if available - histological diagnosis of pelvic
endometriosis up to 10 years before screening.

- Moderate to severe endometriosis-associated pain during the screening period.

- Regular menstrual cycles.

- BMI ≥ 18 kg/m2 at the screening visit. -

Exclusion Criteria:

The subject will be excluded if she:

- Is pregnant or breast feeding or is planning a pregnancy within the duration of the
treatment period of the study.

- Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of
entry into the screening period.

- Has had a surgical history of any major abdominal surgery within 6 months or any
interventional surgery for endometriosis performed within a period of 2 months before
screening.

- Did not respond to prior treatment with GnRH agonists or GnRH antagonists for
endometriosis.

- Has a history of, or known, osteoporosis or other metabolic bone disease.

- Has chronic pelvic pain that is not caused by endometriosis and requires chronic
analgesic or other chronic therapy which would interfere with the assessment of
endometriosis-associated pain.