A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
Start Date
8/14/2023
Completion Date
9/1/2030
Summary
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.
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.
Eligibility Criteria
Age Range: 18 years to 50 years
Interventions
Relugolix Combination Tablet
Conditions
Locations
Mobile
Mobile, Alabama 36604
United States
Chandler
Chandler, Arizona 85224
United States
Mesa
Mesa, Arizona 85209
United States
Peoria
Peoria, Arizona 85381
United States
Phoenix
Phoenix, Arizona 85018
United States
Tucson
Tucson, Arizona 85715-3834
United States
Burbank
Burbank, California 91506-1773
United States
Canoga Park
Canoga Park, California 91303
United States
Encinitas
Encinitas, California 92024-1329
United States
Inglewood
Inglewood, California 90301
United States
Lomita
Lomita, California 90717-2101
United States
Long Beach
Long Beach, California 90805-4587
United States
Los Angeles
Los Angeles, California 90036
United States
Sacramento
Sacramento, California 95817-2307
United States
San Fernando
San Fernando, California 91340-4199
United States
Stanford
Stanford, California 94305-2200
United States
Valley Village
Valley Village, California 91607
United States
Aurora
Aurora, Colorado 80045-2517
United States
Greenwood Village
Greenwood Village, Colorado 80111
United States
Lakewood
Lakewood, Colorado 80228
United States
Washington
Washington D.C., District of Columbia 02011
United States
Aventura
Aventura, Florida 33180
United States
Deland
DeLand, Florida 32720
United States
Hialeah
Hialeah, Florida 33016
United States
Kissimmee
Kissimmee, Florida 34741-2358
United States
Lake Worth
Lake Worth, Florida 33461
United States
Margate
Margate, Florida 33063-5715
United States
Miami
Miami, Florida 33126
United States
Miami
Miami, Florida 33155
United States
Miami
Miami, Florida 33173
United States
Miami Beach
Miami Beach, Florida 33140
United States
Miami Springs
Miami Springs, Florida 33166
United States
New Port Richey
New Port Richey, Florida 34652-4020
United States
New Port Richey
New Port Richey, Florida 34652
United States
Orlando
Orlando, Florida 32808
United States
Orlando
Orlando, Florida 32819
United States
Panama City
Panama City, Florida 32405
United States
Sarasota
Sarasota, Florida 34239
United States
Tamarac
Tamarac, Florida 33321
United States
Tampa
Tampa, Florida 33614-1874
United States
Venice
Venice, Florida 34285
United States
West Palm Beach
West Palm Beach, Florida 33409
United States
Atlanta
Atlanta, Georgia 30342
United States
Atlanta
Atlanta, Georgia 30363
United States
College Park
College Park, Georgia 30349-3103
United States
Fayetteville
Fayetteville, Georgia 31204
United States
Norcross
Norcross, Georgia 30093
United States
Idaho Falls
Idaho Falls, Idaho 83404-8322
United States
Idaho Falls
Idaho Falls, Idaho 83404
United States
Meridian
Meridian, Idaho 83646
United States
Chicago
Chicago, Illinois 60607-4911
United States
Chicago
Chicago, Illinois 60616
United States
Schaumburg
Schaumburg, Illinois 60173-5831
United States
Lenexa
Lenexa, Kansas 66215-2733
United States
Wichita
Wichita, Kansas 67211
United States
Covington
Covington, Louisiana 70433
United States
Marrero
Marrero, Louisiana 70072
United States
Metairie
Metairie, Louisiana 70001
United States
New Orleans
New Orleans, Louisiana 70115-6235
United States
New Orleans
New Orleans, Louisiana 70127
United States
Slidell
Slidell, Louisiana 70458-2004
United States
Baltimore
Baltimore, Maryland 21205
United States
Laurel
Laurel, Maryland 20707-5203
United States
Towson
Towson, Maryland 21204
United States
Bay City
Bay City, Michigan 48706
United States
Dearborn Heights
Dearborn Heights, Michigan 48127
United States
Detroit
Detroit, Michigan 48201
United States
Ridgeland
Ridgeland, Mississippi 39157-5179
United States
Saint Louis
St Louis, Missouri 63108-1495
United States
St Louis
St Louis, Missouri 63141
United States
Grand Island
Grand Island, Nebraska 68803-4327
United States
Norfolk
Norfolk, Nebraska 68701
United States
Las Vegas
Las Vegas, Nevada 89109
United States
North Las Vegas
North Las Vegas, Nevada 89030
United States
West New York
West New York, New Jersey 07093-2622
United States
Durham
Durham, North Carolina 27713
United States
New Bern
New Bern, North Carolina 28562
United States
Raleigh
Raleigh, North Carolina 27607
United States
Raleigh
Raleigh, North Carolina 27612-8104
United States
Winston Salem
Winston-Salem, North Carolina 27103-1749
United States
Cincinnati
Cincinnati, Ohio 45255
United States
Cleveland
Cleveland, Ohio 44124
United States
Columbus
Columbus, Ohio 43213
United States
Columbus
Columbus, Ohio 43231
United States
Dublin
Dublin, Ohio 43016
United States
Englewood
Englewood, Ohio 45322
United States
Middletown
Middletown, Ohio 45005-2593
United States
Erie
Erie, Pennsylvania 16507-1423
United States
Philadelphia
Philadelphia, Pennsylvania 19104
United States
Philadelphia
Philadelphia, Pennsylvania 19114
United States
Bluffton
Bluffton, South Carolina 29910-4883
United States
Greenville
Greenville, South Carolina 29615-4833
United States
Summerville
Summerville, South Carolina 29485-8345
United States
West Columbia
West Columbia, South Carolina 29169
United States
Chattanooga
Chattanooga, Tennessee 37404
United States
Jackson
Jackson, Tennessee 38305
United States
Memphis
Memphis, Tennessee 38119
United States
Memphis
Memphis, Tennessee 38120
United States
Arlington
Arlington, Texas 76012-4705
United States
Dallas
Dallas, Texas 75230-2598
United States
Dallas
Dallas, Texas 75230
United States
Fort Worth
Fort Worth, Texas 76104-4141
United States
Galveston
Galveston, Texas 77555
United States
Houston
Houston, Texas 77021
United States
Houston
Houston, Texas 77024
United States
Houston
Houston, Texas 77030-4514
United States
Houston
Houston, Texas 77054
United States
League City
League City, Texas 77573
United States
Pearland
Pearland, Texas 77584
United States
San Antonio
San Antonio, Texas 78230
United States
San Antonio
San Antonio, Texas 78258
United States
Sugar Land
Sugar Land, Texas 77479-1001
United States
Sugar Land
Sugar Land, Texas 77479
United States
Webster
Webster, Texas 77598-4081
United States
Pleasant Grove
Pleasant Grove, Utah 84062-4097
United States
Salt Lake City
Salt Lake City, Utah 84107
United States
Annandale
Annandale, Virginia 22003-7308
United States
Newport News
Newport News, Virginia 23606
United States
Virginia Beach
Virginia Beach, Virginia 23456-8125
United States
Seattle
Seattle, Washington 98105-4028
United States