Overview

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

Status:
Completed
Trial end date:
2021-05-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Myovant Sciences GmbH
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Norethindrone
Norethindrone Acetate
Polyestradiol phosphate
Relugolix
Criteria
Key Inclusion Criteria:

1. Is a premenopausal female aged 18 to 50 years old (inclusive) on the day of signing of
the informed consent form.

2. Has agreed to use only study-specified analgesic medications during the study and is
not known to be intolerant to these.

3. Has a diagnosis of endometriosis and has had, within 10 years prior to signing the
informed consent form, surgical or direct visualization and/or histopathologic
confirmation of endometriosis, for example, during a laparoscopy or laparotomy.

4. During the Run-In Period (35 to 70 days prior to treatment period) has a dysmenorrhea
NRS score ≥ 4.0 on at least 2 days and

1. Mean NMPP NRS score ≥ 2.5, or

2. Mean NMPP NRS score ≥ 1.25 and NMPP NRS score ≥ 5.0 on ≥ 4 days.

Key Exclusion Criteria:

1. Has a history of chronic pelvic pain that is not caused by endometriosis.

2. Has any chronic pain or frequently recurring pain condition, other than endometriosis
that is treated with opioids or requires analgesics for ≥ 7 days per month.

3. Has had surgical procedures for treatment of endometriosis within the 3 months prior
to the Screening visit.

4. Has a history of or currently has osteoporosis or other metabolic bone disease.

5. Has a clinically significant gynecologic condition, other than endometriosis,
identified during Screening or Run-In period transvaginal ultrasound or endometrial
biopsy.