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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03400956
Other study ID # 15790
Secondary ID 2016-003561-26
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 24, 2018
Est. completion date June 30, 2021

Study information

Verified date June 2022
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 103
Est. completion date June 30, 2021
Est. primary completion date March 23, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vilaprisan (BAY1002670)
Orally, coated tablet 2 mg, once daily
Placebo
Orally, coated tablet, once daily

Locations

Country Name City State
Czechia GynPorCentrum s.r.o. Krnov
Czechia Gynekologie MUDr. Jaromir Karban s.r.o Neratovice
Czechia Privatni gynekologicko-porodnicka ordinace Praha
Czechia GYNEVI s.r.o. Rokycany
Czechia Gynekologicka ambulance - Zabreh na Morave Zabreh Na Morave
Japan Shonan Fujisawa Tokushukai Hospital Fujisawa Kanagawa
Japan Saiseikai Fukuoka General Hospital Fukuoka
Japan Funabashi Municipal Medical Center Funabashi Chiba
Japan Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine Kagoshima
Japan Unoki Clinic Kagoshima
Japan Kosumo Clinic Kako-gun Hyogo
Japan Tsujinaka Hospital Kashiwanoha Kashiwa Chiba
Japan Kobe City Medical Center General Hospital Kobe Hyogo
Japan Four Seasons Ladies' Clinic Kumamoto
Japan Japanese Red Cross Kumamoto Hospital Kumamoto
Japan Omi Medical Center Kusatsu Shiga
Japan Ijinkai Takeda General Hospital Kyoto
Japan Japanese Red Cross Kyoto Daini Hospital Kyoto
Japan Matsudo City General Hospital Matsudo Chiba
Japan Kyoto city Hospital Nakagyo-ku Kyoto
Japan Gokeikai Osaka Kaisei Hospital Osaka
Japan Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi Osaka
Japan Osaka City Hospital Organization Osaka City General Hospital Osaka
Japan Ena Odori Clinic Sapporo Hokkaido
Japan Hashimoto Clinic Sapporo Hokkaido
Japan Tokeidai Memorial Clinic Sapporo Hokkaido
Japan Yoshio Clinic Sapporo Hokkaido
Japan Medical Topia Soka Hospital Soka Saitama
Japan Asahi-Clinic. Takamatsu Kagawa
Japan Kagawa Prefectural Central Hospital Takamatsu Kagawa
Japan Takamatsu Red Cross Hospital Takamatsu Kagawa
Russian Federation Altai State Medical University Barnaul
Russian Federation Maternity Hospital, 17 Saint-Petersburg
Russian Federation Close Joint Stock Company "Medical Company IDK" Samara
Russian Federation Smolensk State Medical University Smolensk
Russian Federation "Granti-Med" St. Petersburg
Russian Federation Med Estetic Center St. Petersburg
Russian Federation Scien. Res. Institute of Obsterics, Gyn. & Reproduction St. Petersburg
Ukraine Chernivtsi Regional Perinatal Center Chernivtsi
Ukraine Vinnytsia City Clinical Maternity Hospital No 2 Vinnytsia
Ukraine Zaporizhzhia Regional Clinical Hospital Zaporizhzhya
United States Women Partners in Health Obstetrics & Gynecology (OB/GYN) Austin Texas
United States Gadolin Research Beaumont Texas
United States Clearview Medical Research, LLC Canyon Country California
United States Women's Medical Research Group, LLC Clearwater Florida
United States Vista Clinical Research Columbia South Carolina
United States Discovery Clinical Trials Dallas Texas
United States Diagnamics, Inc. Encinitas California
United States New England Center for Clinical Research, Inc. Fall River Massachusetts
United States Unified Women's Clinical Research Greensboro North Carolina
United States Vital Pharma Research Hialeah Florida
United States Chattanooga Women for Women Hixson Tennessee
United States Advances in Health, Inc. Houston Texas
United States National Research Institute Huntington Park California
United States Women's Healthcare Associates, PA Idaho Falls Idaho
United States Solutions Through Advanced Research, Inc. Jacksonville Florida
United States The Clinical Trial Center, LLC Jenkintown Pennsylvania
United States Health Awareness, Inc. Jupiter Florida
United States Grossmont Center for Clinical Research La Mesa California
United States West Coast OB/GYN Associates La Mesa California
United States Altea Research Institute Las Vegas Nevada
United States South Florida Clinical Research Institute Margate Florida
United States Advanced Pharma CR, LLC Miami Florida
United States Florida Research Center, Inc. Miami Florida
United States Genoma Research Group, Inc. Miami Florida
United States Miami Dade Medical Research Institute, LLC Miami Florida
United States Palmetto Professional Research Miami Florida
United States Suncoast Research Group, LLC Miami Florida
United States Vista Health Research Miami Florida
United States Savin Medical Group LLC Miami Lakes Florida
United States Tidewater Physicians for Women Norfolk Virginia
United States A Premier Medical Research of Florida, LLC Orange City Florida
United States Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare Orlando Florida
United States Oviedo Medical Research, LLC Oviedo Florida
United States National Research Institute Panorama City California
United States University of Pennsylvania Philadelphia Pennsylvania
United States DMI Research Pinellas Park Florida
United States Oregon Health and Science University Portland Oregon
United States Discovery Clinical Trials San Antonio Texas
United States Artemis Institute for Clinical Research San Diego California
United States Medical Center for Clinical Research San Diego California
United States Physician Care Clinical Research Sarasota Florida
United States Seattle Clinical Research Center Seattle Washington
United States Journey Medical Research Snellville Georgia
United States Center of Reproductive Medicine Webster Texas
United States PMG Research of Wilmington Wilmington North Carolina
United States Unified Women's Clinical Research / Ocala, FL Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Czechia,  Japan,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Amenorrhea Amenorrhea 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. The last 28 days of treatment period 1
Secondary Number of Participants With Heavy Menstrual Bleeding (HMB) Response HMB 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). The last 28 days of treatment period 1 and treatment period 2
Secondary Time to Onset of Amenorrhea Onset 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). In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary Time to Onset of Controlled Bleeding Onset 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). In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Secondary 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). The last 28 days of treatment period 1 and treatment period 2
Secondary 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 without atypia, hyperplasia with atypia and endometrial polyps. Up to 36 weeks
Secondary Change From Baseline of Endometrial Thickness Ultrasound 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. In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
See also
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