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

  • STATUS
    Recruiting
  • End date
    Jul 24, 2022
  • participants needed
    450
  • sponsor
    ObsEva SA
Updated on 24 January 2021
Investigator
investigator
Primary Contact
Continental Clinical Solutions, LLC / ID # 777 (7.6 mi away) Contact
+137 other location
regular menstrual cycles
endometriosis
estradiol
pelvic endometriosis
norethindrone acetate

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).

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.

Details
Treatment Placebo linzagolix tablets and Placebo Add-back capsule, Placebo linzagolix and linzagolix tablets and Placebo Add-back capsule, Placebo linzagolix and linzagolix tablets and Add-back capsule, 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg), Placebo tablet to match 75 mg linzagolix tablet, Placebo tablet to match 200 mg linzagolix tablet, Placebo capsule to match Add-back capsule
Clinical Study IdentifierNCT03986944
SponsorObsEva SA
Last Modified on24 January 2021

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 49 yrs?
Are you female?
Do you have any of these conditions: Endometriosis or Gynecological Infections or Female Genital Diseases?
Do you have any of these conditions: Endometriosis or Female Genital Diseases or Gynecological Infections?
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
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