Trial Condition(s):
Uterine Fibroids
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 4)
Bayer Identifier:
15790
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was to show superiority of vilaprisan in the treatment of heavy menstrual bleeding (HMB) in subjects with uterine fibroids compared to placebo
The secondary objectives of this study were to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids
Inclusion Criteria
- Women, 18 years or older in good general health - Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter more than 30 mm and less than 120 mm - Heavy menstrual bleeding (HMB) in at least 2 bleeding periods during the screening period each with blood loss volume of >80.00 mL documented by the alkaline hematin (AH) method - An endometrial biopsy performed during the screening period without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology - Use of an acceptable non-hormonal method of contraception (ie, either male condom, cap, diaphragm or sponge, each in combination with spermicide) 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 - Hemoglobin values ≤6 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values ≤10.9 g/dL will be recommended to use iron supplementation) - 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 (e.g. laxatives) - Use of other treatments that might interfere with the conduct of the study or the interpretation of results - Undiagnosed abnormal genital bleeding
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Advances in Health, Inc. Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Savin Medical Group LLC Miami Lakes, United States, 33014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Grossmont Center for Clinical Research La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Physician Care Clinical Research Sarasota, United States, 34239 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Solutions Through Advanced Research, Inc. Jacksonville, United States, 32256 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations DMI Research Pinellas Park, United States, 33782 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare Orlando, United States, 32801 | Status Completed | Contact Us: E-mail: clini[email protected] Phone: (+) 1-888-8422937 |
Locations PMG Research of Wilmington Wilmington, United States, 28401 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vista Clinical Research Columbia, United States, 29201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Medical Research Group, LLC Clearwater, United States, 33759 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Seattle Clinical Research Center Seattle, United States, 98105 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women's Clinical Research / Ocala, FL Winston-Salem, United States, 27103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vista Health Research Miami, United States, 33176 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Palmetto Professional Research Miami, United States, 33186 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Clearview Medical Research, LLC Canyon Country, United States, 91351 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Diagnamics, Inc. Encinitas, United States, 92024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oviedo Medical Research, LLC Oviedo, United States, 32765 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Journey Medical Research Snellville, United States, 30078 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unified Women’s Clinical Research Greensboro, United States, 27408 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Miami Dade Medical Research Institute, LLC Miami, United States, 33176 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Pennsylvania Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations New England Center for Clinical Research, Inc. Fall River, United States, 02720 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations The Clinical Trial Center, LLC Jenkintown, United States, 19046 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Altea Research Institute Las Vegas, United States, 89102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women's Healthcare Associates, PA Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chattanooga Women for Women Hixson, United States, 37343 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Discovery Clinical Trials Dallas, United States, 75231 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vital Pharma Research Hialeah, United States, 33016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Discovery Clinical Trials San Antonio, United States, 78258 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Center for Clinical Research San Diego, United States, 92108 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Health Awareness, Inc. Jupiter, United States, 33458 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A Premier Medical Research of Florida, LLC Orange City, United States, 32763 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Artemis Institute for Clinical Research San Diego, United States, 92103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologicka ambulance - Zabreh na Morave Zabreh na Morave, Czech Republic, 78901 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gynekologie MUDr. Jaromir Karban s.r.o Neratovice, Czech Republic, 277 11 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Privatni gynekologicko-porodnicka ordinace Praha, Czech Republic, 16000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GYNEVI s.r.o. Rokycany, Czech Republic, 337 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations GynPorCentrum s.r.o. Krnov, Czech Republic, 794 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Center of Reproductive Medicine Webster, United States, 77598 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Suncoast Research Group, LLC Miami, United States, 33135 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tidewater Physicians for Women Norfolk, United States, 23502 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Oregon Health and Science University Portland, United States, 97239-3011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Genoma Research Group, Inc. Miami, United States, 33165 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations South Florida Clinical Research Institute Margate, United States, 33073 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Florida Research Center, Inc. Miami, United States, 33174 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Advanced Pharma CR, LLC Miami, United States, 33147 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Research Institute Huntington Park, United States, 90255 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gadolin Research Beaumont, United States, 77702 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations West Coast OB/GYN Associates LA Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Smolensk State Medical University Smolensk, Russia, 214019 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Med Estetic Center St. Petersburg, Russia, 192177 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Close Joint Stock Company "Medical Company IDK" Samara, Russia, 443067 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Maternity Hospital, 17 Saint-Petersburg, Russia, 192174 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations "Granti-Med" St. Petersburg, Russia, 198329 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Scien. Res. Institute of Obsterics, Gyn. & Reproduction St. Petersburg, Russia, 199034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Altai State Medical University Barnaul, Russia, 656038 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vinnytsia City Clinical Maternity Hospital No 2 Vinnytsia, Ukraine, 21001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Chernivtsi Regional Perinatal Center Chernivtsi, Ukraine, 58001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Zaporizhzhia Regional Clinical Hospital Zaporizhzhya, Ukraine, 69103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Research Institute Panorama City, United States, 91402 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hashimoto Clinic Sapporo, Japan, 004-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Yoshio Clinic Sapporo, Japan, 064-0808 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tokeidai Memorial Clinic Sapporo, Japan, 060-0031 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Topia Soka Hospital Soka, Japan, 340-0028 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ena Odori Clinic Sapporo, Japan, 060-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kagawa Prefectural Central Hospital Takamatsu, Japan, 760-8557 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Unoki Clinic Kagoshima, Japan, 892-0826 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Asahi-Clinic. Takamatsu, Japan, 760-0076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kyoto city Hospital Nakagyo-ku, Japan, 604-8845 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takamatsu Red Cross Hospital Takamatsu, Japan, 760-0017 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Gokeikai Osaka Kaisei Hospital Osaka, Japan, 532-0003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine Kagoshima, Japan, 892-0845 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Matsudo City General Hospital Matsudo, Japan, 270-2296 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka City Hospital Organization Osaka City General Hospital Osaka, Japan, 534-0021 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ijinkai Takeda General Hospital Kyoto, Japan, 601-1495 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tsujinaka Hospital Kashiwanoha Kashiwa, Japan, 277-0871 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi Osaka, Japan, 542-0086 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations FOUR SEASONS LADIES’ CLINIC Kumamoto, Japan, 860-0846 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Funabashi Municipal Medical Center Funabashi, Japan, 273-8588 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Saiseikai Fukuoka General Hospital Fukuoka, Japan, 810-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations OMI MEDICAL CENTER Kusatsu, Japan, 525-8585 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Women Partners in Health Obstetrics & Gynecology (OB/GYN) Austin, United States, 78705 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kobe City Medical Center General Hospital Kobe, Japan, 650-0047 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kosumo Clinic Kako-gun, Japan, 675-1115 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Japanese Red Cross Kyoto Daini Hospital Kyoto, Japan, 602-8026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A randomized, parallel-group, double-blind and placebo-controlled, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Number of participants with amenorrheaAmenorrhea was defined as menstrual blood loss (MBL) < 2 mL during the last 28 days of treatment. The evaluation of MBL was based on the Alkaline hematin (AH) method.Timeframe: The last 28 days of treatment period 1
Secondary Outcome
- Number of participants with heavy Menstrual Bleeding (HMB) responseHMB was defined as MBL <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline (assessed by the AH method).Timeframe: The last 28 days of treatment period 1 and treatment period 2
- Time to onset of amenorrheaOnset of amenorrhea was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was <2 mL (amenorrhea defined similar to primary endpoint and assessed by the AH method).Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
- Time to onset of controlled bleedingOnset of controlled bleeding was defined by the first day for which the MBL for all subsequent 28-day periods up to the end of a treatment period was <80.00 mL (assessed by the AH method).Timeframe: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
- Number of participants with absence of bleeding (spotting allowed)Absence of bleeding was defined as no scheduled or unscheduled bleeding (spotting allowed) during the last 28 days of a treatment period based on subjects’ daily responses to the UF-DBD (Uterine Fibroid Daily Bleeding Diary).Timeframe: The last 28 days of treatment period 1 and treatment period 2
- Number of participants by endometrial biopsy main results (majority read, main diagnosis)Number of participants with endometrial histology findings, e.g. benign endometrium, Malignant Neoplasm, Hyperplasia 2014, no atypia or Hyperplasia 2014, atypia and Endometrial Polyps.Timeframe: Up to 36 weeks
- Change from baseline of 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 in endometrial thickness was provided in below table.Timeframe: Up to 36 weeks
Additional Information
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