Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)

Uterine Fibroids Clinical Trial

Official title:

A Randomized, Parallel-group, Double-blind and Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03400956
• Other study ID #: 15790
• Secondary ID: 2016-003561-26
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

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)

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