A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis
Recruiting · Phase 3 · NCT05862272
Conditions: Uterine Fibroids, Endometriosis
At a glance
- Research payments reported, 2025
- $4.9M
- U.S. investigators named
- 125
- Sites paid
- 106
- Planned or actual enrollment
- 1,000
About the trial
- Sponsor
- Sumitomo Pharma Switzerland GmbH
- Tested
- Relugolix Combination Tablet (drug)
- Dates
- Started 2023-08-14; completion 2030-09
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2025-08-06. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sumitomo Pharma America, Inc. reported $4.9M in research payments for this study in 2025 (1,584 payments).
Products named: Orgovyx, Myfembree
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Theodore N. Catranis, M.D. OB-GYN (Obstetrics & Gynecology) · Mobile, AL
- Ronald W. Orso, MD OB-GYN (Obstetrics & Gynecology) · Birmingham, AL
- Ramana K. Puppala, M.D. OB-GYN (Obstetrics & Gynecology) · Greenville, AL
- Ali Azadi, M.D. Urogynecology · Peoria, AZ
- Catherine P. Brainard, MD OB-GYN (Obstetrics & Gynecology) · Tucson, AZ
- Ernesto M. Gomez, M.D. OB-GYN (Obstetrics & Gynecology) · Mesa, AZ
- Joseph L. Lillo, DO, FNLA, FAPCR Family Medicine · Scottsdale, AZ
- Gregory J. Marchand, M.D. OB-GYN (Obstetrics & Gynecology) · Mesa, AZ
- Muhammad M. Salim, MD Pulmonology · Chandler, AZ
- Hessam Aazami, M.D. General Practice · Canoga Park, CA
- Vellore R. Bhupathy, MD OB-GYN (Obstetrics & Gynecology) · Whittier, CA
- Paul D. Blumenthal, MD OB-GYN (Obstetrics & Gynecology) · Stanford, CA
- Mitchell Creinin, MD OB-GYN (Obstetrics & Gynecology) · Sacramento, CA
- Ashley Duzik, DO Family Medicine · Tarzana, CA
- Ramin H. Farsad, M.D. Family Medicine · Encinitas, CA
- Suzanne L. Fussell, MD Family Medicine · Oxnard, CA
- Soheil P. Hekmat, MD Internal Medicine · Inglewood, CA
- Jose M. Medrano, MD OB-GYN (Obstetrics & Gynecology) · Burbank, CA
- Marina Raikhel, MD Family Medicine · Lomita, CA
- Robert J. Semo, MD OB-GYN (Obstetrics & Gynecology) · San Diego, CA
- Farid Yasharpour, M.D. Specialist · San Fernando, CA
- Michael P. Johnson, M.D. OB-GYN (Obstetrics & Gynecology) · Lakewood, CO
- Jill H. Liss, MD OB-GYN (Obstetrics & Gynecology) · Aurora, CO
- Michael L. Moore, M.D. OB-GYN (Obstetrics & Gynecology) · Denver, CO
- Kristin N. Mcday, MD OB-GYN (Obstetrics & Gynecology) · Washington, DC
- James A. Simon, M.D. OB-GYN (Obstetrics & Gynecology) · Washington, DC
- Ronald T. Ackerman SR., MD OB-GYN (Obstetrics & Gynecology) · West Palm Beach, FL
- Kwabena Ayesu, MD Internal Medicine · Orlando, FL
- Lidia R. Bermudez, MD Family Medicine · Hialeah, FL
- Peter J. Casella, MD OB-GYN (Obstetrics & Gynecology) · Kissimmee, FL
- Lisa M. Cohen, D. O. Family Medicine · Palm Harbor, FL
- Yamirka Duardo-guerra, M.D. Family Medicine · Miami, FL
- Hugo M. Ferrara, M.D. OB-GYN (Obstetrics & Gynecology) · Hialeah, FL
- Helena M. Gaviria, MD Pediatrics · Tamarac, FL
- Harvey A. Glasser, MD OB-GYN (Obstetrics & Gynecology) · Aventura, FL
- Ausberto B. Hidalgo General Practice · Pembroke Pines, FL
- Keila Hoover, M.D. Family Medicine · Miami, FL
- Blake C. Landry, MD OB-GYN (Obstetrics & Gynecology) · Orlando, FL
- Samuel N. Lederman, M.D. OB-GYN (Obstetrics & Gynecology) · Lake Worth, FL
- Guillermo A. Lievano JR., DO OB-GYN (Obstetrics & Gynecology) · Miami, FL
- Godson I. Oguchi, M.D. Infectious Disease · Orange City, FL
- Shani S. Reich, M.D. Ophthalmology · Miami, FL
- Ivonne M. Reynolds, DO OB-GYN (Obstetrics & Gynecology) · Margate, FL
- Robert L. Smith JR., M.D. OB-GYN (Obstetrics & Gynecology) · New Port Richey, FL
- Gregory M. Swor, MD Urogynecology · Sarasota, FL
- Antonio E. Terrelonge, MD Family Medicine · Miami, FL
- Samuel B. Wolf, D.O. OB-GYN (Obstetrics & Gynecology) · Panama City, FL
- Nadia G. Cameron, M.D. Family Medicine · Lawrenceville, GA
- Michelle Y. Evans, M.D. Family Medicine · Atlanta, GA
- Melinda Miller-thrasher, M.D. Specialist · Atlanta, GA
- David H. Montaldi, MD OB-GYN (Obstetrics & Gynecology) · Marietta, GA
- Winifred L. Soufi, M.D. Specialist · Atlanta, GA
- Timothy P. Villegas, M.D. OB-GYN (Obstetrics & Gynecology) · Columbus, GA
- Jeffrey B. Baker, M.D. Family Medicine · Idaho Falls, ID
- Glenn R. Leavitt, DO OB-GYN (Obstetrics & Gynecology) · Idaho Falls, ID
- Kelly Siudzinski, M.D. OB-GYN (Obstetrics & Gynecology) · Meridian, ID
- Dennis J. Levinson, M.D. Internal Medicine · Chicago, IL
- Errin L. Manney, MD Family Medicine · Frankfort, IL
- Arundathi G. Prasad, M.D. OB-GYN (Obstetrics & Gynecology) · Indianapolis, IN
- Gordon B. Clark, MD Obesity Medicine · Shawnee, KS
- David A. Grainger, MD Fertility (Reproductive Endocrinology) · Wichita, KS
- Samuel M. Alexander, M.D. OB-GYN (Obstetrics & Gynecology) · Metairie, LA
- William F. Beacham, M.D. OB-GYN (Obstetrics & Gynecology) · Hammond, LA
- Clifton S. Nicholson-uhl, M.D OB-GYN (Obstetrics & Gynecology) · Marrero, LA
- Brandon L. Perez, M.D. OB-GYN (Obstetrics & Gynecology) · Marrero, LA
- Albert I. Tydings, MD OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Michele S. Goh, MD Internal Medicine · Hudson, MA
- Alyssa R. Kratochvil, DO OB-GYN (Obstetrics & Gynecology) · Fall River, MA
- Issam A. Daya, M.D. OB-GYN (Obstetrics & Gynecology) · Towson, MD
- James H. Segars JR., MD Fertility (Reproductive Endocrinology) · Baltimore, MD
- Jay M. Berman, MD OB-GYN (Obstetrics & Gynecology) · Southfield, MI
- Mona Y. Fakih, D.O. OB-GYN (Obstetrics & Gynecology) · Dearborn Heights, MI
- Duane B. Heilbronn JR., M.D. OB-GYN (Obstetrics & Gynecology) · Saginaw, MI
- Henry J. Youga, MD Family Medicine · Manistee, MI
- David L. Eisenberg, MD OB-GYN (Obstetrics & Gynecology) · Saint Louis, MO
- Saji Jacob, MD OB-GYN (Obstetrics & Gynecology) · St. Louis, MO
- Bob Hutchins Internal Medicine · Jackson, MS
- Jeremy M. Belch, M.D., M.P.H. OB-GYN (Obstetrics & Gynecology) · New Bern, NC
- Ann S. Collins, MD OB-GYN (Obstetrics & Gynecology) · Raleigh, NC
- Rebecca F. Dunsmoor-su, MD OB-GYN (Obstetrics & Gynecology) · Morrisville, NC
- Amber G. Hatch, M.D. OB-GYN (Obstetrics & Gynecology) · Winston Salem, NC
- Andrea S. Lukes, M.D. OB-GYN (Obstetrics & Gynecology) · Durham, NC
- Jeffrey A. Michelson, M.D. OB-GYN (Obstetrics & Gynecology) · New Bern, NC
- Erica L. Haake, M.D. OB-GYN (Obstetrics & Gynecology) · Grand Island, NE
- Keith W. Vrbicky, M.D. OB-GYN (Obstetrics & Gynecology) · Norfolk, NE
- Rita V. Knause, MD OB-GYN (Obstetrics & Gynecology) · Tenafly, NJ
- Carrie D. Swartz, M.D. OB-GYN (Obstetrics & Gynecology) · Albuquerque, NM
- Nader Y. Abdelsayed, MEDICAL DOCTOR OB-GYN (Obstetrics & Gynecology) · North Las Vegas, NV
- Tawni J. Christensen, MD General Practice · Las Vegas, NV
- Angelina K. Gangestad, MD OB-GYN (Obstetrics & Gynecology) · Cleveland, OH
- Harold N. Green, MD OB-GYN (Obstetrics & Gynecology) · Columbus, OH
- Tifany N. Nolan, MD OB-GYN (Obstetrics & Gynecology) · Batavia, OH
- Gerard P. Reilly, M.D. OB-GYN (Obstetrics & Gynecology) · Cincinnati, OH
- Milroy J. Samuel, MD OB-GYN (Obstetrics & Gynecology) · Columbus, OH
- Stuart A. Weprin, M.D. OB-GYN (Obstetrics & Gynecology) · Englewood, OH
- Kimberly A. Bowman, MD OB-GYN (Obstetrics & Gynecology) · Norman, OK
- Jeffrey T. Jensen, MD OB-GYN (Obstetrics & Gynecology) · Portland, OR
- Eugene Andruczyk, D.O. OB-GYN (Obstetrics & Gynecology) · Philadelphia, PA
- Michael A. Scutella, MD OB-GYN (Obstetrics & Gynecology) · Erie, PA
- Sarita R. Sonalkar, MD OB-GYN (Obstetrics & Gynecology) · Philadelphia, PA
- Tasha M. Boone, MD Family Medicine · Irmo, SC
- Luis De La Cruz, MD Sleep Medicine · Spartanburg, SC
- Ronnie M. Givens II, MD OB-GYN (Obstetrics & Gynecology) · Summerville, SC
- Patricia A. Thompson, MD OB-GYN (Obstetrics & Gynecology) · Beaufort, SC
- Benjamin T. Chappell, M.D. OB-GYN (Obstetrics & Gynecology) · Memphis, TN
- Daniel S. Harnsberger, M.D. OB-GYN (Obstetrics & Gynecology) · Chattanooga, TN
- Lora J. Mcgill, M.D. Neurology · Memphis, TN
- Christopher Welsch, M.D. OB-GYN (Obstetrics & Gynecology) · Jackson, TN
- Sandra M. Hurtado, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Mark A. Jacobs, M.D. OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Anna M. Lizama Clark, M.D. OB-GYN (Obstetrics & Gynecology) · Dallas, TX
- Brian K. Macgillivray, MD Family Medicine · San Antonio, TX
- Bassem Maximos, MD, MPH, PA OB-GYN (Obstetrics & Gynecology) · League City, TX
- Dawnette Peppler, M.D. OB-GYN (Obstetrics & Gynecology) · Arlington, TX
- Yvette M. Poindexter, MD Family Medicine · Pearland, TX
- Cynthia J. Robbins, M.D. OB-GYN (Obstetrics & Gynecology) · Fort Worth, TX
- Luis A. Sandoval Martinez, M.D OB-GYN (Obstetrics & Gynecology) · Houston, TX
- Stephanie C. Slocum, M.D. OB-GYN (Obstetrics & Gynecology) · Dallas, TX
- Jennefer C. Sutton, MD Family Medicine · San Antonio, TX
- Jerome L. Yaklic, MD OB-GYN (Obstetrics & Gynecology) · Galveston, TX
- Mara L. Rabin, M.D. Family Medicine · Salt Lake City, UT
- David B. Young, D.O. OB-GYN (Obstetrics & Gynecology) · Pleasant Grove, UT
- George H. Freeman, M.D. Research Study Specialist · Newport News, VA
- Camilla C. Hersh, M.D. OB-GYN (Obstetrics & Gynecology) · Reston, VA
- Franklin C. Morgan, M.D. OB-GYN (Obstetrics & Gynecology) · Norfolk, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Alfa Medical Research $551,717
- Discovery Clinical Trials $337,811
- Ideal Clinical Research Inc $262,293
- Ocean Blue Medical Research Center Inc $199,828
- Tmc Life Research Inc $175,945
- Eastern Clinical Research $156,278
- Elligo Health Research Inc $139,347
- Helios Clinical Research Inc $133,113
- Interspond LLC $127,740
- Miami Clinical Research Lllp $105,962
- Seattle Crc LLC $105,409
- Sunbelt Research Group LLC $103,436
- Emerald Coast Obgyn Clinical Research LLC $101,225
- Lcc Medical Research Institute LLC $99,082
- Velocity Clinical Research Inc $96,405
- Amicis Research Center $95,733
- Pharmaseek LLC $93,672
- Chattanooga Medical Research LLC $85,451
- Del Sol Research Management LLC $66,288
- Clinical Trials Management LLC $61,604
- Cwrwc $61,461
- Elias Research Associates LLC $60,967
- Exordia Medical Research Inc $60,598
- Praetorian Pharmaceutical Research LLC $57,632
- Agile Clinical Research Trials LLC $56,410
- Chandler Clinical Trials LLC $53,047
- University of California Davis Medical Center, CA $48,782
- Tidewater Clinical Research Inc $45,808
- Revive Research Institute Inc $43,578
- Hospital of Univ of Pennsylvania, PA $42,986
- Wr Crcn LLC $42,384
- Emerson Clinical Research Institute Inc $42,171
- Physicians Research Options LLC $40,873
- South Florida Wellness & Clinical Research Institute LLC $40,699
- Advanced Womens Health Institute $40,325
- Affiliated Clinical Research Inc $40,089
- Sky Clinical Research Network Group $39,012
- Long Beach Research Institute $37,467
- Diagnamics Inc $35,784
- Ohsu Hospital and Clinics, OR $34,087
- Southern Clinical Research Associates LLC $33,616
- Focus Clinical Research Solutions LLC $33,567
- Suncoast Clinical Research Inc $32,946
- Cactus Clinical Research Inc $30,928
- Biocentric LLC $30,322
- Continental Clinical Solutions LLC $30,147
- The University of Texas Health $30,137
- Vida Clinical Research LLC $29,426
- Unified Women's Clinical Research $29,199
- Omega Research Orlando LLC $29,029
- Vital Pharma Research $28,671
- Genoma Research Group Inc $28,623
- Fellows Research Alliance Inc $26,477
- Seven Hills Ob Gyn Associates $26,344
- Stanford University $26,056
- Bassem Maximos MD Mph PA $25,955
- The Jackson Clinic PA $25,952
- Wayne State University $24,173
- University Hospitals Cleveland Medical Center $22,978
- Square One Clinical Research Inc $22,033
- Intimmedicine Specialists $21,301
- Clinical Research Prime $19,373
- Center for Clinical Research LLC $18,064
- Washington University $17,935
- Next Innovative Clinical Reseach $15,628
- Long Beach Clinical Trials Ser $15,445
- Clinical Associates of Orlando $14,833
- Physicians Research Group LLC $11,779
- Health Research of Hampton Road Inc $11,233
- Quantum Clinical of Dade Count $10,500
- Washington University School of Medicine $10,353
- Investigator Research Group LLC $10,310
- Vip Trials $10,213
- Clinical Neuroscience Solution $10,103
- Pivotal Clinical Research and Associates LLC $9,623
- Altus Clinical Research LLC $9,536
- Viva Capital Funding LLC $9,065
- Torrance Clinical Research $8,935
- Olympia Clinical Trials $8,442
- Midland Florida Clinical Research Ctr LLC $8,392
- Johns Hopkins University $7,614
- University of Texas Medical Branch Galveston, TX $7,339
- M3 Wake Research Inc $6,618
- Columbus Regional Research Ins $6,490
- Great Lakes Research Group Inc $6,400
- Wasatch Clinical Research LLC $5,393
- Paramount Research Solutions $4,695
- R and B Medical Center LLC $4,376
- Physician Care Clinical Research LLC $4,300
- Palmetto Clinical Research $4,200
- Lynn Health Science Institute $3,150
- Cypress Medical Research Cente $3,085
- Chicago Clinical Research Institute Inc $2,500
- Sandhill Research LLC $2,150
- Leavitt Clinical Research Inc $2,100
- Comprehensive Clinical Researc $1,991
- Elite Clinical Studies LLC $1,921
- Health Research of Hampton Medical Center $1,730
- Hwc Womens Research Center LLC $1,588
- Clinical Research Philadelphia LLC $1,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.