A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

Purpose

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).

Condition

  • Endometriosis

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Linzagolix 75 mg
  • Drug: 75 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo tablet to match 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo capsule to match Add-back capsule
    For oral administration once daily
Experimental
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
  • Drug: 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg)
    For oral administration once daily
  • Drug: Placebo tablet to match 75 mg linzagolix tablet
    For oral administration once daily
Placebo Comparator
Placebo
  • Drug: Placebo tablet to match 75 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo tablet to match 200 mg linzagolix tablet
    For oral administration once daily
  • Drug: Placebo capsule to match Add-back capsule
    For oral administration once daily

More Details

Status
Terminated
Sponsor
ObsEva SA

Study Contact

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.