Trial Condition(s):
Uterine Fibroids
Assess safety and efficacy of Vilaprisan in subjects with uterine fibroids (ASTEROID 6)
Bayer Identifier:
16953
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The study was performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care
Inclusion Criteria
-18 years or older -Diagnosis of uterine fibroid(s) documented by ultrasound at screening AND/OR during a uterine preserving procedure within 3 months prior to screening in subjects with high risk for recurrence - At least one symptom of uterine fibroid(s) - bleeding, pelvic pressure/pain -Good general health -Normal or clinically insignificant cervical smear -An endometrial biopsy performed during the screening period, without significant histological disorder -Use of an acceptable nonhormonal method of contraception starting at Visit 1 until the end of the study
Exclusion Criteria
-Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) -Hypersensitivity to any ingredient of the study drug -Any condition requiring immediate blood transfusion -Any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug -Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results -Abuse of alcohol, drugs, or medicines (eg, laxatives) -Use of other treatments that might interfere with the conduct of the study or the interpretation of the results -Undiagnosed abnormal genital bleeding
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Clinical Research Philadelphia | Philadelphia, PA Philadelphia, United States, 19114 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lyndhurst Clinical Research Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research - Morehead City Morehead City, United States, 28557 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Carolina Women's Research & Wellness Center Durham, United States, 27713 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Visions Clinical Research - Tucson Tucson, United States, 85712 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Columbia University Medical Center New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Helix Biomedics LLC | Boynton Beach, FL Boynton Beach, United States, 33435 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advances in Health, INC. | Houston, TX Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women’s Clinical Research Greensboro, United States, 27408 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HWC Women's Research Center | Englewood, OH Englewood, United States, 45322 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Woman's Hospital of Texas Houston, United States, 77054 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Centex Studies, Inc. Lake Charles, United States, 70601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sig Gyn Services (Dr. John A. Whitfield, MD) | Fort Worth, TX Fort Worth, United States, 76104-4145 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations M3 Wake Research | Raleigh, NC Raleigh, United States, 27612 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations OB-GYN Physicians, Inc. Franklin, United States, 23851 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Women's Clinic of Lincoln, P.C. | Lincoln, NE Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Discovery Clinical Trials - Dallas Dallas, United States, 75231 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations M & O Clinical Research, LLC Ft. Lauderdale, United States, 33316 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Virginia Physicians For Women North Chesterfield, United States, 23235 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Agile Clinical Research Trials, LLC Atlanta, United States, 30328 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bosque Women's Care | Albuquerque, NM Albuquerque, United States, 87109 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Office of Dr. Delbert Alan Johns, MD Fort Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suncoast Clinical Research Inc. | Pasco Trinity, United States, 34655 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yale University School of Medicine New Haven, United States, 06511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Lynn Health Science Institute | Lynn Institute of the Ozarks Little Rock, United States, 72204 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Swor Women's Care Sarasota, United States, 34239 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Center For Women's Research Palos Heights, United States, 60463 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Continental Clinical Solutions | Towson, MD Towson, United States, 21204 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Diagnamics | Encinitas, CA Encinitas, United States, 92024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vista Clinical Research Columbia, United States, 29201 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The 2nd Hospital of Hebei Medical University Shijiazhuang, China, 50000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Health Alliance Raleigh, United States, 27607 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations MultiCare Health Systems Women's Health Care Covington, United States, 98042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Drexel University College of Medicine Philadelphia, United States, 19102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital of the University of Pennsylvania Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Valaoras & Lewis OB/GYN Winston-Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Research Integrity, LLC Owensboro, United States, 42303 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations ClinSearch, LLC Hixson, United States, 37421 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Physician Group Memphis, United States, 38104 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations MacArthur OB/GYN Mangement, LLC Irving, United States, 75062 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Grossmont Center for Clinical Research La Mesa, United States, 91942 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Venus Gynecology, LLC | Myrtle Beach, SC Myrtle Beach, United States, 29572 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Baltimore Suburban Health, LLC Pikesville, United States, 21208 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical University of South Carolina | MUSC Center for Womens Health - Department of Obstetrics and Gynecology Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Synexus Research, LLC Richmond, United States, 23226 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Invocare Clinical Research Center, LLC West Columbia, United States, 29169 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ONCOVA Clinical Research, Inc. Saint Cloud, United States, 34769 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Family Medicine Clinic Georgetown, United States, 78626 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Eastern Carolina Women's Center | New Bern, NC New Bern, United States, 28562 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jersey Shore University Medical Center Neptune, United States, 07753 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scien. Res. Institute of Obsterics, Gyn. & Reproduction St. Petersburg, Russia, 199034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations "Granti-Med" St. Petersburg, Russia, 198329 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Petersburg Medical University n.a. I.P. Pavlov St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Endocrinology Research Center Moscow, Russia, 117036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krasnoyarsk regional perinatal center Krasnoyarsk, Russia, 660074 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scientific Center of family health & human reprod. problems Irkutsk, Russia, 664003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peking University First Hospital Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations First Teaching Hosptial of Tianjin University of TCM Tianjin, China, 300193 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Ginza Yoshida Clinic Chuo-ku, Japan, 104-0061 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mehilainen | Mehilainen Kuopio Kuopio, Finland, 70100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Trial Design
An open-label, parallel-group, randomized, multicenter study to assess the safety and efficacy of vilaprisan in subjects with uterine fibroids versus standard of care
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Percentage change in bone mineral density (BMD) of lumbar spineThe percentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine from baseline to about one year after start of treatment (SoT) in all randomized and treated participants with measurements at those 2 time points in each treatment group.Timeframe: From baseline to about 1 year after start of treatment
Secondary Outcome
- Number of bleeding daysNumber of bleeding days were defined from Day 1 of the first treatment period until the day before a new treatment period would start again following the last treatment period for that respective treatment group. Number to be normalized by 28 daysTimeframe: Treatment phase: approximately 1 year
- Number of participants with endometrial histology findings by endometrial biopsy main results (majority read, main diagnosis)Number of participants with endometrial histology findings, e.g. benign endometrium, presence or absence of hyperplasia or malignancyTimeframe: Up to 3 years (from study treatment start to end of study)
- Change from baseline in endometrial thicknessUltrasound examinations were performed. Endometrial thickness was measured in the medio-sagittal section as double-layer in millimeters. Summary statistics for change from baseline (worst measurement during baseline period) in endometrial thickness was provided in below table.Timeframe: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
- Percentage change from baseline in BMD measured at lumbar spine (other time points not mentioned as primary safety variable) and hip/femoral neckPercentage change in BMD (measured by dual-energy X-ray absorptiometry (DEXA) scan) of lumbar spine (other time points not mentioned as primary safety analysis), hip, and femoral neck from baseline was analyzed using the same statistical methods as used for the primary variable.Timeframe: Treatment phase: approximately 1 year, follow-up phase: up to 2 years
Additional Information
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