Clinical trial NCT03400956: Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 4)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Heavy menstrual bleeding
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Amenorrhea
timeFrame: The last 28 days of treatment period 1
Secondary outcomes:
measure: Number of Participants With Heavy Menstrual Bleeding (HMB) Response
timeFrame: The last 28 days of treatment period 1 and treatment period 2
measure: Time to Onset of Amenorrhea
timeFrame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
measure: Time to Onset of Controlled Bleeding
timeFrame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
measure: Number of Participants With Absence of Bleeding (Spotting Allowed)
timeFrame: The last 28 days of treatment period 1 and treatment period 2
measure: Number of Participants by Endometrial Biopsy Main Results (Majority Read, Main Diagnosis)
timeFrame: Up to 36 weeks
measure: Change From Baseline of Endometrial Thickness
timeFrame: In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
Other outcomes:
Locations:
city: Canyon Country
country: United States
facility: Clearview Medical Research, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: La Mesa
country: United States
facility: Grossmont Center for Clinical Research
state: California
city: La Mesa
country: United States
facility: West Coast OB/GYN Associates
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: Clearwater
country: United States
facility: Women's Medical Research Group, LLC
state: Florida
city: Hialeah
country: United States
facility: Vital Pharma Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Margate
country: United States
facility: South Florida Clinical Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Miami
country: United States
facility: Palmetto Professional Research
state: Florida
city: Orange City
country: United States
facility: A Premier Medical Research of Florida, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neurosciences Solutions, Inc. DBA CNS Healthcare
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Sarasota
country: United States
facility: Physician Care Clinical Research
state: Florida
city: Snellville
country: United States
facility: Journey Medical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Women's Healthcare Associates, PA
state: Idaho
city: Fall River
country: United States
facility: New England Center for Clinical Research, Inc.
state: Massachusetts
city: Las Vegas
country: United States
facility: Altea Research Institute
state: Nevada
city: Greensboro
country: United States
facility: Unified Women's Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research / Ocala, FL
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Vista Clinical Research
state: South Carolina
city: Hixson
country: United States
facility: Chattanooga Women for Women
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health Obstetrics & Gynecology (OB/GYN)
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Houston
country: United States
facility: Advances in Health, Inc.
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Norfolk
country: United States
facility: Tidewater Physicians for Women
state: Virginia
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Krnov
country: Czechia
facility: GynPorCentrum s.r.o.
city: Neratovice
country: Czechia
facility: Gynekologie MUDr. Jaromir Karban s.r.o
city: Praha
country: Czechia
facility: Privatni gynekologicko-porodnicka ordinace
city: Rokycany
country: Czechia
facility: GYNEVI s.r.o.
city: Zabreh Na Morave
country: Czechia
facility: Gynekologicka ambulance - Zabreh na Morave
city: Funabashi
country: Japan
facility: Funabashi Municipal Medical Center
state: Chiba
city: Kashiwa
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
state: Chiba
city: Matsudo
country: Japan
facility: Matsudo City General Hospital
state: Chiba
city: Sapporo
country: Japan
facility: Hashimoto Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Ena Odori Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Tokeidai Memorial Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yoshio Clinic
state: Hokkaido
city: Kako-gun
country: Japan
facility: Kosumo Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital
state: Kagawa
city: Takamatsu
country: Japan
facility: Asahi-Clinic.
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
state: Kagawa
city: Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
state: Kanagawa
city: Nakagyo-ku
country: Japan
facility: Kyoto city Hospital
state: Kyoto
city: Soka
country: Japan
facility: Medical Topia Soka Hospital
state: Saitama
city: Kusatsu
country: Japan
facility: Omi Medical Center
state: Shiga
city: Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Kagoshima
country: Japan
facility: Unoki Clinic
city: Kagoshima
country: Japan
facility: Tetsu-Nakamura Obstetrics and Gynecology Internal Medicine
city: Kumamoto
country: Japan
facility: Four Seasons Ladies' Clinic
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kyoto
country: Japan
facility: Ijinkai Takeda General Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Osaka
country: Japan
facility: Gokeikai Osaka Kaisei Hospital
city: Osaka
country: Japan
facility: Osaka City Hospital Organization Osaka City General Hospital
city: Osaka
country: Japan
facility: Medical Co. LEADING GIRLS Women's Clinic LUNA Shinsaibashi
city: Barnaul
country: Russian Federation
facility: Altai State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: Maternity Hospital, 17
city: Samara
country: Russian Federation
facility: Close Joint Stock Company "Medical Company IDK"
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: St. Petersburg
country: Russian Federation
facility: Med Estetic Center
city: St. Petersburg
country: Russian Federation
facility: "Granti-Med"
city: St. Petersburg
country: Russian Federation
facility: Scien. Res. Institute of Obsterics, Gyn. & Reproduction
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Perinatal Center
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Maternity Hospital No 2
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhia Regional Clinical Hospital
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: