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

This study is currently recruiting participants.
Verified November 2017 by Myovant Sciences GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT03204318
First Posted: July 2, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Myovant Sciences GmbH
June 27, 2017
July 2, 2017
November 17, 2017
June 27, 2017
December 2019   (Final data collection date for primary outcome measure)
  • Proportion of responders based on daily assessment of dysmenorrhea [ Time Frame: 24 weeks ]
    As recorded in a daily electronic diary
  • Proportion of responders based on daily assessment of nonmenstrual pelvic pain [ Time Frame: 24 weeks ]
    As recorded in a daily electronic diary
Same as current
Complete list of historical versions of study NCT03204318 on ClinicalTrials.gov Archive Site
Change from Baseline in the Endometriosis Health Profile (EHP)-30 Pain Domain Group [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Endometriosis Related Pain
  • Drug: Relugolix
    Relugolix 40 mg oral tablet
  • Drug: Relugolix Placebo
    Sugar pill manufactured to match relugolix in size, shape, color and odor
  • Drug: Low-dose Hormonal Add-back
    Over-encapsulated estradiol 1.0 mg and norethindrone acetate 0.5 mg co-formulated tablet
    Other Name: Add-back
  • Drug: Low-dose Hormonal Add-back Placebo
    Over-encapsulated sugar pill manufactured to match estradiol and norethindrone acetate co-formulated tablet
    Other Names:
    • Add-back Pbo
    • estradiol and norethindrone acetate placebo
  • Experimental: Relugolix + Low-dose Hormonal Add-back
    Relugolix 40 mg oral tablet co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) once daily for 24 weeks.
    Interventions:
    • Drug: Relugolix
    • Drug: Low-dose Hormonal Add-back
  • Experimental: Relugolix + Add-back Pbo -> Relugolix + Add-back
    Relugolix 40 mg oral tablet co-administered with low dose hormonal add-back placebo, once daily for 12 weeks, followed by relugolix 40 mg oral tablet co-administered with estradiol (1.0 mg) and norethindrone acetate (0.5 mg) once daily for 12 weeks.
    Interventions:
    • Drug: Relugolix
    • Drug: Low-dose Hormonal Add-back
    • Drug: Low-dose Hormonal Add-back Placebo
  • Placebo Comparator: Relugolix Placebo + Add-back Placebo
    Placebo relugolix oral tablet co-administered with low dose hormonal add-back placebo, once daily for 24 weeks.
    Interventions:
    • Drug: Relugolix Placebo
    • Drug: Low-dose Hormonal Add-back Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2020
December 2019   (Final data collection date for primary outcome measure)

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.

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.
  3. Has had gynecological surgery or other surgical procedures for treatment of endometriosis within the 3 months prior to the Screening visit.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact: Clinical Trials at Myovant 650-278-8743 ClinicalTrials@Myovant.com
United States
 
 
NCT03204318
MVT-601-3101
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Myovant Sciences GmbH
Myovant Sciences GmbH
Not Provided
Study Director: Myovant Medical Monitor Myovant Sciences
Myovant Sciences GmbH
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP