ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Relugolix SPIRIT
Previous Study | Return to List | Next Study

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

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.
ClinicalTrials.gov Identifier: NCT03204331
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Myovant Sciences GmbH

Brief Summary:
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 or disease Intervention/treatment Phase
Endometriosis Related Pain Drug: Relugolix Drug: Relugolix Placebo Drug: Low-dose Hormonal Add-back Drug: Low-dose Hormonal Add-back Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Proportion of responders based on daily assessment of dysmenorrhea [ Time Frame: 24 weeks ]
    As recorded in a daily electronic diary

  2. 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 :
  1. Change from Baseline in the Endometriosis Health Profile (EHP)-30 Pain Domain Group [ Time Frame: 24 weeks ]


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.

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

  Hide Study Locations
Locations
United States, Alabama
Andalusia Recruiting
Andalusia, Alabama, United States, 34420
United States, Florida
Aventura Recruiting
Aventura, Florida, United States, 33180
Brandon Recruiting
Brandon, Florida, United States, 33510
Deland Recruiting
DeLand, Florida, United States, 32720
Hialeah Recruiting
Hialeah, Florida, United States, 33016
Margate Not yet recruiting
Margate, Florida, United States, 33063
Miami Recruiting
Miami, Florida, United States, 33176
Port St. Lucie Recruiting
Port Saint Lucie, Florida, United States, 34952
Tampa Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta Recruiting
Atlanta, Georgia, United States, 30328
Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Sandy Springs Recruiting
Sandy Springs, Georgia, United States, 30328
United States, Idaho
Idaho Falls Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Indiana
Lafayette Recruiting
Lafayette, Indiana, United States, 47905
United States, Louisiana
Covington Recruiting
Covington, Louisiana, United States, 70433
Marrero Recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Baltimore Recruiting
Baltimore, Maryland, United States, 21212
United States, Michigan
Bay City Recruiting
Bay City, Michigan, United States, 48706
Saginaw Recruiting
Saginaw, Michigan, United States, 48604
United States, Missouri
St. Louis Recruiting
Saint Louis, Missouri, United States, 63108
St. Louis Recruiting
Saint Louis, Missouri, United States, 63141
United States, Nevada
Las Vegas Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Mexico
Albuquerque Recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
New York Recruiting
New York, New York, United States, 10038
United States, North Carolina
Charlotte Recruiting
Charlotte, North Carolina, United States, 28210
United States, Ohio
Columbus Recruiting
Columbus, Ohio, United States, 43231
Columbus Recruiting
Columbus, Ohio, United States, 43235
Dayton Recruiting
Dayton, Ohio, United States, 45409
United States, South Carolina
Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29340
United States, Tennessee
Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Texas
Austin Recruiting
Austin, Texas, United States, 78705
Beaumont Recruiting
Beaumont, Texas, United States, 77702
Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Houston Recruiting
Houston, Texas, United States, 77054
San Antionio Recruiting
San Antonio, Texas, United States, 78258
Sugar Land Recruiting
Sugar Land, Texas, United States, 77479
United States, Utah
Salt Lake City Recruiting
Salt Lake City, Utah, United States, 84107
United States, Virginia
Virginia Beach Recruiting
Virginia Beach, Virginia, United States, 23456
United States, Washington
Covington Recruiting
Covington, Washington, United States, 98042
Australia, New South Wales
Blacktown Recruiting
Blacktown, New South Wales, Australia
Kanwal Recruiting
Kanwal, New South Wales, Australia
Sydney Recruiting
Sydney, New South Wales, Australia
Australia, Queensland
Kippa Ring Recruiting
Kippa-Ring, Queensland, Australia
Sherwood Recruiting
Sherwood, Queensland, Australia
Australia, Western Australia
Nedlands Recruiting
Nedlands, Western Australia, Australia
Canada, Ontario
Sarnia Recruiting
Sarnia, Ontario, Canada, N7T4X3
Canada, Quebec
Quebec City Recruiting
Quebec City, Quebec, Canada, G1S2L6
Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Czechia
Písek Recruiting
Písek, Jihocesky KRAJ, Czechia
Tábor Recruiting
Tábor, Jihormoravsky KRAJ, Czechia
Prague Recruiting
Prague, Praha, Czechia
Praha 10 Recruiting
Praha 10, Czechia
Praha 6 Recruiting
Praha, Czechia
Ceské Budejovice Recruiting
České Budějovice, Czechia
Georgia
Tbilisi Recruiting
Tbilisi, Borjomi, Georgia
Italy
Catanzaro Recruiting
Catanzaro, Italy
Napoli Recruiting
Napoli, Italy
Roma Recruiting
Roma, Italy
Siena Recruiting
Siena, Italy
New Zealand
Tauranga Recruiting
Tauranga, Bay Of Plenty, New Zealand
Palmerston North Recruiting
Palmerston North, Manawatu-wanganui, New Zealand
Remuera Recruiting
Remuera, Queensland, New Zealand
Christchurch Recruiting
Christchurch, New Zealand
Poland
Lublin Recruiting
Lublin, Lubelskie, Poland
Kraków Recruiting
Kraków, Malopolskie, Poland
Warszawa Recruiting
Warszawa, Mazowieckie, Poland
Bialystok Recruiting
Bialystok, Podlaskie, Poland
Warszawa Recruiting
Warszawa, Podlaskie, Poland
Poznan Recruiting
Poznan, Wielkopolskie, Poland
Lodz Recruiting
Łódź, Poland
Sweden
Danderyd Recruiting
Danderyd, Sweden
Stockholm Recruiting
Stockholm, Sweden
United Kingdom
Nottingham Recruiting
Nottingham, England, United Kingdom
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
Study Director: Myovant Medical Monitor Myovant Sciences

Responsible Party: Myovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT03204331     History of Changes
Other Study ID Numbers: MVT-601-3102
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
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