NCT03204318

SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Myovant Sciences GmbH · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.

Detailed description

This study is an international phase 3 randomized, double-blind, placebo-controlled efficacy and safety study to evaluate 24 weeks of oral, once-daily relugolix (40 mg) co-administered with either 12 or 24 weeks of low-dose E2 (1.0 mg) and NETA (0.5 mg), compared with placebo. Approximately 600 women with endometriosis-associated pain will be enrolled and randomized 1:1:1 to Group A - relugolix plus low-dose hormonal add-back therapy, Group B - relugolix monotherapy for 12 weeks followed by co-administration with low-dose hormonal add-back therapy, or Group C - placebo (N = 200 per group). Eligible participants were randomized on Baseline Day 1 to Treatment Group A, B, or C, in the double-blind period. Eligible participants, including those randomized to placebo, were offered the opportunity to enroll in an 80-week open-label extension study where participants received relugolix co-administered with low-dose E2 and NETA. Participants who did not enroll into the extension study had a Follow-Up visit approximately 30 days after the participant's last dose of study drug.

Conditions

• Endometriosis Related Pain

Interventions

Type	Name	Description
DRUG	Relugolix	Relugolix 40-mg tablet administered orally once daily.
DRUG	Estradiol/norethindrone acetate	Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
DRUG	Estradiol/norethindrone acetate placebo	E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
DRUG	Relugolix placebo	Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.

Timeline

• Start date: 2017-12-07
• Primary completion: 2020-06-09
• Completion: 2021-04-08
• First posted: 2017-07-02
• Last updated: 2021-06-28

Locations

123 sites across 13 countries: United States, Argentina, Belgium, Bulgaria, Canada, Czechia, Finland, Hungary, Poland, Portugal, South Africa, Spain, Ukraine

Regulatory

• FDA-regulated drug study