SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Conditions

• Endometriosis Related Pain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Nov 1, 2017

Status verified

Jun 2021

Primary completion

Apr 1, 2020

Completion

May 31, 2021

Study Design

Enrollment

623 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Relugolix plus E2/NETA (Group A)
  Relugolix co-administered with E2/NETA for 24 weeks.
• Experimental: Relugolix plus Delayed E2/NETA (Group B)
  Relugolix co-administered with E2/NETA placebo for 12 weeks, followed by relugolix co-administered with E2/NETA for 12 weeks.
• Placebo Comparator: Placebo (Group C)
  Relugolix placebo co-administered with E2/NETA placebo for 24 weeks.

Primary Outcome Measure

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 24 Or End Of Treatment (EOT) [ Time Frame: Week 24 or EOT ]

Locations (41)

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