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



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 50
Updated:4/6/2019
Start Date:December 7, 2017
End Date:June 30, 2020
Contact:Clinical Trials at Myovant
Email:ClinicalTrials@Myovant.com
Phone:650-278-8743

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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

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

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 estradiol (1.0 mg) and norethindrone acetate (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).

Once eligibility has been confirmed, patients will be randomized on Baseline Day 1 to
Treatment Group A, B or C, and will begin double-blinded study drug treatment on Day 1.
Between the Baseline Day 1 and Week 24 visits, patients will attend visits every 4 weeks, and
will take the blinded study treatment (1 tablet and 1 capsule) orally once daily for 24
weeks. The last dose of study drug will be taken on the day prior to the Week 24 visit.

Eligible patients, including women randomized to placebo, will be offered the opportunity to
enroll in a 28-week open label extension study where patients will receive relugolix
co-administered with low-dose estradiol and norethindrone acetate. Patients who do not enroll
into the extension study will have a Follow-Up visit approximately 30 days after the
patient's last dose of study drug.

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 with surgical visualization of endometriosis via
laparoscopy or laparotomy performed within 10 years prior to signing the informed
consent form.

4. During the Run-In Period has a dysmenorrhea NRS score ≥ 4.0 on at least 2 days AND

- Mean NMPP NRS score ≥ 2.5, OR

- 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 gynecological surgery or other 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 identified during Screening or
Run-In period transvaginal ultrasound or endometrial biopsy.
We found this trial at
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San Diego, California
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Anaheim, California 92804
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Augusta, Georgia 30912
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Bradenton, Florida 34209
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Canoga Park, California 91303
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Cerritos, California 90703
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Clermont, Florida 34711
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Dothan, Alabama 36303
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Durham, North Carolina 27710
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Englewood, Ohio 45322
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Fort Myers, Florida 33912
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Hershey, Pennsylvania 17033
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1590 West 49th Street
Hialeah, Florida 33012
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1332 New York 10
Jefferson, New York 11177
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Jefferson City, Missouri 65109
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Loxahatchee Groves, Florida 33470
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Metairie, Louisiana 70006
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Tucson, Arizona 85724
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