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SPIRIT 2: 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:
NCT03204331
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
  Purpose
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.

Condition Intervention Phase
Endometriosis Related Pain Drug: Relugolix Drug: Relugolix Placebo Drug: Low-dose Hormonal Add-back Drug: Low-dose Hormonal Add-back Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: SPIRIT 2: 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

Resource links provided by NLM:


Further study details as provided by Myovant Sciences GmbH:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change from Baseline in the Endometriosis Health Profile (EHP)-30 Pain Domain Group [ Time Frame: 24 weeks ]

Estimated Enrollment: 600
Actual Study Start Date: August 30, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Relugolix
Relugolix 40 mg oral tablet
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
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.
Drug: Relugolix
Relugolix 40 mg oral tablet
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
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.
Drug: Relugolix Placebo
Sugar pill manufactured to match relugolix in size, shape, color and odor
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

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204331


Contacts
Contact: Clinical Trials at Myovant 650-278-8743 clinicaltrials@myovant.com

  Show 26 Study Locations
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences
  More Information

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03204331     History of Changes
Other Study ID Numbers: MVT-601-3102
First Submitted: June 27, 2017
First Posted: July 2, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myovant Sciences GmbH:
Endometriosis
Pain
Dysmenorrhea

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral