A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
July 31, 2025 updated by: Sumitomo Pharma Switzerland GmbH
A Phase 3B, Single-Arm, Open-Label Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids or Moderate to Severe Pain Associated With Endometriosis
The purpose of this clinical trial to characterize changes in bone mineral density during continuous treatment with relugolix combination tablet for up to 48 months (4 years) and 1 year of post-treatment follow-up in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) or with moderate-to-severe pain associated with endometriosis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A prospective, single-arm, open-label, Phase 3B study to assess the effect of continuous 48 months (4 years) of treatment with relugolix combination tablet (relugolix 40 mg/estradiol [E2] 1 mg/norethindrone acetate [NETA] 0.5 mg) on bone mineral density in premenopausal women with heavy menstrual bleeding associated with uterine leiomyomas (fibroids) and premenopausal women with moderate to severe pain associated with endometriosis.
Approximately 1000 women (500 with heavy menstrual bleeding associated with uterine fibroids and 500 with moderate to severe pain associated with endometriosis) will receive relugolix combination tablet, during which time BMD will be assessed by dual-energy X-ray absorptiometry every 6 months.
A subset of participants will be eligible to enter this study following completion of 1 year of treatment with relugolix combination therapy in MVT-601-050 (NCT04756037; SERENE) and will complete 3 years of treatment under this protocol.
Upon completion of 48 months (4 years) of treatment or after early termination of treatment, participants will enter a 1-year post-treatment follow-up period during which time bone mineral density will be assessed at Month 6 and Month 12 following treatment cessation.
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials at Myovant
- Phone Number: 650-278-8743
- Email: ClinicalTrials@Myovant.com
Study Locations
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Alabama
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Mobile, Alabama, United States, 36604
- Recruiting
- Mobile
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Arizona
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Chandler, Arizona, United States, 85224
- Recruiting
- Chandler
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Mesa, Arizona, United States, 85209
- Recruiting
- Mesa
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Peoria, Arizona, United States, 85381
- Recruiting
- Peoria
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Phoenix, Arizona, United States, 85018
- Recruiting
- Phoenix
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Tucson, Arizona, United States, 85715-3834
- Recruiting
- Tucson
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California
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Burbank, California, United States, 91506-1773
- Recruiting
- Burbank
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Canoga Park, California, United States, 91303
- Recruiting
- Canoga Park
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Encinitas, California, United States, 92024-1329
- Recruiting
- Encinitas
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Inglewood, California, United States, 90301
- Recruiting
- Inglewood
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Lomita, California, United States, 90717-2101
- Recruiting
- Lomita
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Long Beach, California, United States, 90805-4587
- Recruiting
- Long Beach
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Los Angeles, California, United States, 90036
- Recruiting
- Los Angeles
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Sacramento, California, United States, 95817-2307
- Recruiting
- Sacramento
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San Fernando, California, United States, 91340-4199
- Recruiting
- San Fernando
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Stanford, California, United States, 94305-2200
- Recruiting
- Stanford
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Valley Village, California, United States, 91607
- Recruiting
- Valley Village
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Colorado
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Aurora, Colorado, United States, 80045-2517
- Recruiting
- Aurora
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Greenwood Village, Colorado, United States, 80111
- Recruiting
- Greenwood Village
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Lakewood, Colorado, United States, 80228
- Recruiting
- Lakewood
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District of Columbia
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Washington, District of Columbia, United States, 02011
- Recruiting
- Washington
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Florida
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Aventura, Florida, United States, 33180
- Recruiting
- Aventura
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Deland, Florida, United States, 32720
- Recruiting
- Deland
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Hialeah, Florida, United States, 33016
- Recruiting
- Hialeah
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Kissimmee, Florida, United States, 34741-2358
- Recruiting
- Kissimmee
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Lake Worth, Florida, United States, 33461
- Recruiting
- Lake Worth
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Margate, Florida, United States, 33063-5715
- Recruiting
- Margate
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Miami, Florida, United States, 33126
- Recruiting
- Miami
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Miami, Florida, United States, 33155
- Recruiting
- Miami
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Miami, Florida, United States, 33173
- Recruiting
- Miami
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Miami Beach, Florida, United States, 33140
- Recruiting
- Miami Beach
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Miami Springs, Florida, United States, 33166
- Recruiting
- Miami Springs
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New Port Richey, Florida, United States, 34652
- Recruiting
- New Port Richey
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New Port Richey, Florida, United States, 34652-4020
- Recruiting
- New Port Richey
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Orlando, Florida, United States, 32808
- Recruiting
- Orlando
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Orlando, Florida, United States, 32819
- Recruiting
- Orlando
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Panama City, Florida, United States, 32405
- Recruiting
- Panama City
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Sarasota, Florida, United States, 34239
- Recruiting
- Sarasota
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Tamarac, Florida, United States, 33321
- Recruiting
- Tamarac
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Tampa, Florida, United States, 33614-1874
- Recruiting
- Tampa
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Venice, Florida, United States, 34285
- Recruiting
- Venice
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West Palm Beach, Florida, United States, 33409
- Recruiting
- West Palm Beach
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Georgia
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Atlanta, Georgia, United States, 30363
- Recruiting
- Atlanta
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Atlanta, Georgia, United States, 30342
- Recruiting
- Atlanta
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College Park, Georgia, United States, 30349-3103
- Recruiting
- College Park
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Fayetteville, Georgia, United States, 31204
- Recruiting
- Fayetteville
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Norcross, Georgia, United States, 30093
- Recruiting
- Norcross
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Recruiting
- Idaho Falls
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Idaho Falls, Idaho, United States, 83404-8322
- Recruiting
- Idaho Falls
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Meridian, Idaho, United States, 83646
- Recruiting
- Meridian
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Illinois
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Chicago, Illinois, United States, 60616
- Recruiting
- Chicago
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Chicago, Illinois, United States, 60607-4911
- Recruiting
- Chicago
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Schaumburg, Illinois, United States, 60173-5831
- Recruiting
- Schaumburg
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Kansas
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Lenexa, Kansas, United States, 66215-2733
- Recruiting
- Lenexa
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Wichita, Kansas, United States, 67211
- Recruiting
- Wichita
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Louisiana
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Covington, Louisiana, United States, 70433
- Recruiting
- Covington
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Marrero, Louisiana, United States, 70072
- Recruiting
- Marrero
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Metairie, Louisiana, United States, 70001
- Recruiting
- Metairie
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New Orleans, Louisiana, United States, 70127
- Recruiting
- New Orleans
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New Orleans, Louisiana, United States, 70115-6235
- Recruiting
- New Orleans
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Slidell, Louisiana, United States, 70458-2004
- Recruiting
- Slidell
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Maryland
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Baltimore, Maryland, United States, 21205
- Recruiting
- Baltimore
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Laurel, Maryland, United States, 20707-5203
- Recruiting
- Laurel
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Towson, Maryland, United States, 21204
- Recruiting
- Towson
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Michigan
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Bay City, Michigan, United States, 48706
- Recruiting
- Bay City
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Dearborn Heights, Michigan, United States, 48127
- Recruiting
- Dearborn Heights
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Detroit, Michigan, United States, 48201
- Recruiting
- Detroit
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Mississippi
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Ridgeland, Mississippi, United States, 39157-5179
- Recruiting
- Ridgeland
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Missouri
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Saint Louis, Missouri, United States, 63108-1495
- Recruiting
- Saint Louis
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St Louis, Missouri, United States, 63141
- Recruiting
- St Louis
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Nebraska
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Grand Island, Nebraska, United States, 68803-4327
- Recruiting
- Grand Island
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Norfolk, Nebraska, United States, 68701
- Recruiting
- Norfolk
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Nevada
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Las Vegas, Nevada, United States, 89109
- Recruiting
- Las Vegas
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North Las Vegas, Nevada, United States, 89030
- Recruiting
- North Las Vegas
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New Jersey
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W. New York, New Jersey, United States, 07093-2622
- Recruiting
- West New York
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North Carolina
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Durham, North Carolina, United States, 27713
- Recruiting
- Durham
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New Bern, North Carolina, United States, 28562
- Recruiting
- New Bern
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Raleigh, North Carolina, United States, 27607
- Recruiting
- Raleigh
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Raleigh, North Carolina, United States, 27612-8104
- Recruiting
- Raleigh
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Winston Salem, North Carolina, United States, 27103-1749
- Recruiting
- Winston Salem
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Ohio
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Cincinnati, Ohio, United States, 45255
- Recruiting
- Cincinnati
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Cleveland, Ohio, United States, 44124
- Recruiting
- Cleveland
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Columbus, Ohio, United States, 43213
- Recruiting
- Columbus
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Columbus, Ohio, United States, 43231
- Recruiting
- Columbus
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Dublin, Ohio, United States, 43016
- Recruiting
- Dublin
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Englewood, Ohio, United States, 45322
- Recruiting
- Englewood
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Middletown, Ohio, United States, 45005-2593
- Recruiting
- Middletown
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Pennsylvania
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Erie, Pennsylvania, United States, 16507-1423
- Recruiting
- Erie
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Philadelphia
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Philadelphia, Pennsylvania, United States, 19114
- Recruiting
- Philadelphia
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South Carolina
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Bluffton, South Carolina, United States, 29910-4883
- Recruiting
- Bluffton
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Greenville, South Carolina, United States, 29615-4833
- Recruiting
- Greenville
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Summerville, South Carolina, United States, 29485-8345
- Recruiting
- Summerville
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West Columbia, South Carolina, United States, 29169
- Recruiting
- West Columbia
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Recruiting
- Chattanooga
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Jackson, Tennessee, United States, 38305
- Recruiting
- Jackson
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Memphis, Tennessee, United States, 38120
- Recruiting
- Memphis
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Memphis, Tennessee, United States, 38119
- Recruiting
- Memphis
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Texas
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Arlington, Texas, United States, 76012-4705
- Recruiting
- Arlington
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Dallas, Texas, United States, 75230
- Recruiting
- Dallas
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Dallas, Texas, United States, 75230-2598
- Recruiting
- Dallas
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Fort Worth, Texas, United States, 76104-4141
- Recruiting
- Fort Worth
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Galveston, Texas, United States, 77555
- Recruiting
- Galveston
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Houston, Texas, United States, 77021
- Recruiting
- Houston
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Houston, Texas, United States, 77024
- Recruiting
- Houston
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Houston, Texas, United States, 77054
- Recruiting
- Houston
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Houston, Texas, United States, 77030-4514
- Recruiting
- Houston
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League City, Texas, United States, 77573
- Recruiting
- League City
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Pearland, Texas, United States, 77584
- Recruiting
- Pearland
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San Antonio, Texas, United States, 78258
- Recruiting
- San Antonio
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San Antonio, Texas, United States, 78230
- Recruiting
- San Antonio
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Sugar Land, Texas, United States, 77479
- Recruiting
- Sugar Land
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Sugar Land, Texas, United States, 77479-1001
- Recruiting
- Sugar Land
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Webster, Texas, United States, 77598-4081
- Recruiting
- Webster
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Utah
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Pleasant Grove, Utah, United States, 84062-4097
- Recruiting
- Pleasant Grove
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Salt Lake City, Utah, United States, 84107
- Recruiting
- Salt Lake City
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Virginia
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Annandale, Virginia, United States, 22003-7308
- Recruiting
- Annandale
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Newport News, Virginia, United States, 23606
- Recruiting
- Newport News
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Virginia Beach, Virginia, United States, 23456-8125
- Recruiting
- Virginia Beach
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Washington
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Seattle, Washington, United States, 98105-4028
- Recruiting
- Seattle
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- Is a premenopausal woman, 18 to 50 years of age (inclusive);
- A diagnosis of uterine fibroids confirmed by imaging or review of medical records and reports heavy menstrual bleeding negatively affecting quality of life. or
- A diagnosis of endometriosis that is associated with moderate to severe pain.;
- If at risk of pregnancy is willing to avoid pregnancy for 4 years (the duration of the treatment period) using nonhormonal methods of contraception.
- Has a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the allocation visit (or Month 12 if entering from MVT-601-050 [NCT04756037; SERENE]);
- In good physical and mental health based on medical, surgical, and gynecological history as well as physical, gynecological, and breast examinations, clinical laboratory test results, and vital sign measurements;
- Has a body mass index ≥ 18 kg/m^2.
Key Exclusion Criteria:
- Has a weight or body habitus that exceeds the limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine or proximal femur
Has a DXA result demonstrating the following criteria at any anatomic site (lumbar spine, total hip, femoral neck):
- For patients entering de novo a Z-score ≤ -1.5 or T-score ≤ -2.0 (if ≥ 40 years of age)
- For patients entering from MVT-601-050 (NCT04756037; SERENE) a 12-month on-treatment DXA demonstrating Z-score ≤ -2.0, T-score ≤ -2.5 (if ≥ 40 years of age), or BMD loss ≥ 8% compared with pre-treatment baseline;
- Screening 25-OH vitamin D level < 12 ng/mL (patients with 25-OH vitamin D deficiency with levels ≥ 12 to < 20 ng/mL are permitted if supplementing with vitamin D or if vitamin D supplementation is started in the screening period);
- Has a history of or currently has Cushing's Syndrome, Rheumatoid Arthritis, metabolic bone disease, uncorrected hyperparathyroidism, Paget's disease of the bone, collagen vascular disease, Marfan's syndrome, Ehlers-Danlos syndrome (if confirmed on genetic testing or meets definitive criteria for hypermobility type), chronic kidney disease (CKD) stage 3 or greater with glomerular filtration rate (GFR) < 60 mL/min/m2 using Modification of Diet in Renal Disease (MDRD) method, hyperprolactinemia, known pituitary adenoma, hyperthyroidism, anorexia nervosa, bulimia (within the last year), abnormal bone mineral metabolism (eg, hypophosphatemia). Patients whose hyperparathyroidism or hyperthyroidism has been successfully treated or whose hyperprolactinemia has been successfully treated are allowed;
- History of low trauma (fragility) fracture.
- Past history of use or current use of medication used to treat bone loss other than calcium and vitamin D preparations;
- Prior use of depot-medroxyprogesterone acetate for a treatment period > 2 years (if treatment occurred within the past 5 years) or prior use of GnRH agonist or antagonist for > 12 months total (unless directly entering from MVT-601-050 [NCT04756037; SERENE]);
- Malabsorptive disease (including, but not limited to, inflammatory bowel disease and gastric bypass surgery);
- Current breast cancer, history of breast cancer or other hormone-sensitive malignancy, at increased risk for hormone-sensitive malignancy, or taking an aromatase inhibitor for breast cancer treatment or prevention
- History of organ transplantation or history of bone marrow
- BIRADS ≥ 3 Mammogram at entry (or within the past 6 months).
- Has a known human immunodeficiency virus (HIV) infection or at high risk of contracting HIV
- Has a current psychiatric disorder that would, in the investigator or medical monitor's opinion, impair the ability of the patient to participate in the study or would impair interpretation of their data.
- Is currently using a hormonal intrauterine device or contraceptive implant, hormonal contraceptive, or other prohibited medication and is unwilling to discontinue this hormonal contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Relugolix Combination Tablet
Participants will receive relugolix combination therapy orally once daily for 48 months.
|
A fixed-dose combination tablet containing relugolix 40 mg, estradiol (E2) 1 mg, and norethindrone acetate (NETA) 0.5 mg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in women with endometriosis.
Time Frame: Baseline up to Month 48
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Assessed by dual-energy X-ray absorptiometry (DXA) scan.
|
Baseline up to Month 48
|
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Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.
Time Frame: Baseline up to Month 48
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
|
Baseline up to Month 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with uterine fibroids.
Time Frame: Baseline up to Month 48
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
|
Baseline up to Month 48
|
|
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in women with endometriosis.
Time Frame: Baseline up to Month 48
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan.
|
Baseline up to Month 48
|
|
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time Frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
|
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time Frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
|
Percent change from baseline in BMD at Month 48 on-treatment at lumbar spine (L1-L4) in the overall study population.
Time Frame: Baseline up to Month 48
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
Baseline up to Month 48
|
|
Percent change from baseline in BMD at Month 48 on-treatment at total hip and femoral neck in the overall study population.
Time Frame: Baseline up to Month 48
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
Baseline up to Month 48
|
|
Percent change from baseline in BMD at Month 6, 12, 18, 24, 30, 36, and 42 on-treatment at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time Frame: Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
Baseline up to Month 6, 12, 18, 24, 30, 36, and 42
|
|
Percent change from baseline in BMD at post-treatment follow-up (PTFU) Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
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Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
|
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with uterine fibroids.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
|
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in women with endometriosis.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
|
Percent change from baseline in BMD at PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
|
Percent change from last on-treatment BMD measurement to PTFU Month 6 and PTFU Month 12 at the lumbar spine (L1-L4), total hip, and femoral neck in the overall study population.
Time Frame: 6 months and 12 months post treatment
|
Assessed by dual-energy X-ray absorptiometry (DXA) scan at each designated time points.
|
6 months and 12 months post treatment
|
|
Incidence of treatment-emergent serious adverse events, and non-serious adverse events leading to treatment discontinuation or withdrawal from the study during the 48 months of treatment.
Time Frame: Baseline up to Month 48
|
Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population.
The treatment-emergent period will be defined as the period of time from the date of the first dose of the study drug through 14 days after the last dose of study drug, or the date of initiation of another investigational agent or hormonal therapy affecting the hypothalamic-pituitary gonadal axis or surgical intervention for uterine fibroids or for endometriosis, whichever occurs first.
|
Baseline up to Month 48
|
|
Incidence and location of fractures during the 48 months on treatment and 12 months PTFU.
Time Frame: Baseline up to Month 48 and 12 months post treatment
|
Safety analyses will be conducted by each safety population: 1) women with uterine fibroids, 2) women with endometriosis, and 3) overall population.
All adverse events will be coded to preferred term and system organ class using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0 or higher.
The incidence of fractures will also be summarized by anatomical sites and whether the fracture qualifies as a fragility fracture.
A participant reporting the same adverse event more than once is counted once, and at the maximum severity or strongest relationship to study drug treatment when calculating incidence.
|
Baseline up to Month 48 and 12 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Myovant Medical Director, Myovant Sciences GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2023
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
September 1, 2030
Study Registration Dates
First Submitted
May 8, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
August 6, 2025
Last Update Submitted That Met QC Criteria
July 31, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Connective Tissue Diseases
- Neoplasms by Histologic Type
- Genital Diseases, Female
- Neoplasms, Connective and Soft Tissue
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Endometriosis
- Leiomyoma
- Myofibroma
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Androgen Antagonists
- Relugolix
Other Study ID Numbers
- MVT-601A-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ospedale Policlinico San MartinoCompletedEndometriosis | Bowel Endometriosis | Endometriosis, Rectum | Endometriosis ColonItaly
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...CompletedEndometriosis | Endometriosis-related Pain | Endometriosis Thoracic | Endometriosis of Lung | Endometriosis of PleuraItaly
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Ospedale Policlinico San MartinoCompletedEndometriosis, Rectum | Endometriosis, SigmoidItaly
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Semmelweis UniversityUniversity of PecsNot yet recruitingEndometriosis | Endometriosis Ovary | Endometriosis Rectovaginal Septum
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Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
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IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknownBowel Endometriosis | Endometriosis, RectumItaly
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Ospedale Policlinico San MartinoActive, not recruitingEndometriosis, Rectum | Endometriosis of ColonItaly
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Catholic University of the Sacred HeartCompletedPelvic Endometriosis | Endometriosis Outside PelvisItaly
Clinical Trials on Relugolix Combination Tablet
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Sumitomo Pharma Switzerland GmbHCompleted
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Endeavor HealthPfizerWithdrawn
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University of UtahRecruitingMetastatic Hormone-sensitive Prostate Cancer (mHSPC)United States
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National Cancer Institute, NaplesActive, not recruitingProstate Cancer (Adenocarcinoma)Italy
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Chipscreen Biosciences, Ltd.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
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Yale UniversityPfizerRecruiting
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Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2 | DiabetesUnited States, Puerto Rico
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TakedaCompleted
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PfizerCompletedProstate CancerUnited States
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Main Line HealthPfizer; Sumitomo Pharma Switzerland GmbHRecruitingEndometriosisUnited States