Phase 3
N=484
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT03992846 ↗Enrolled (actual)
484
Serious AEs
0.6%
Results posted
May 2024
Primary outcome: Primary: Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders — 44.0; 72.9; 23.5 Percentage of responders — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 75 mg linzagolix tablet (Drug); 200 mg linzagolix tablet (Drug); Add-back capsule (E2 1 mg / NETA 0.5 mg) (Drug); Placebo tablet to match 75 mg linzagolix tablet (Drug); Placebo tablet to match 200 mg linzagolix tablet (Drug); Placebo capsule to match Add-back capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders |
44.0; 72.9; 23.5 | <0.001 sig |
| PRIMARY Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders |
38.9; 47.3; 30.9 | 0.279 |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03992846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.