stop_circleTerminated/Withdrawn

Uterine fibroids

Bayer Identifier:

15790

ClinicalTrials.gov Identifier:

NCT03400956

EudraCT Number:

2016-003561-26

EU CT Number:

Not Available
Assess Safety and Efficacy of Vilaprisan in Subjects with Uterine Fibroids (ASTEROID 4)

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

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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
  • - 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
103
Trial Dates
January 2018 - June 2021
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Advances in Health, Inc.Houston, 77030, United States
Completed
Savin Medical Group LLCMiami Lakes, 33014, United States
Completed
Grossmont Center for Clinical ResearchLa Mesa, 91942, United States
Completed
Physician Care Clinical ResearchSarasota, 34239, United States
Completed
Solutions Through Advanced Research, Inc.Jacksonville, 32256, United States
Completed
DMI ResearchPinellas Park, 33782, United States
Completed
Clinical Neurosciences Solutions, Inc. DBA CNS HealthcareOrlando, 32801, United States
Completed
PMG Research of WilmingtonWilmington, 28401, United States
Completed
Vista Clinical ResearchColumbia, 29201, United States
Completed
Women's Medical Research Group, LLCClearwater, 33759, United States
Completed
Seattle Clinical Research CenterSeattle, 98105, United States
Completed
Unified Women's Clinical Research / Ocala, FLWinston-Salem, 27103, United States
Completed
Vista Health ResearchMiami, 33176, United States
Completed
Palmetto Professional ResearchMiami, 33186, United States
Completed
Clearview Medical Research, LLCCanyon Country, 91351, United States
Completed
Diagnamics, Inc.Encinitas, 92024, United States
Completed
Oviedo Medical Research, LLCOviedo, 32765, United States
Withdrawn
Women's Health PracticeChampaign, 61820, United States
Completed
Journey Medical ResearchSnellville, 30078, United States
Withdrawn
University of CincinnatiCincinnati, 45267, United States
Completed
Unified Women’s Clinical ResearchGreensboro, 27408, United States
Completed
Miami Dade Medical Research Institute, LLCMiami, 33176, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States
Completed
New England Center for Clinical Research, Inc.Fall River, 02720, United States
Completed
The Clinical Trial Center, LLCJenkintown, 19046, United States
Completed
Altea Research InstituteLas Vegas, 89102, United States
Completed
Women's Healthcare Associates, PAIdaho Falls, 83404, United States
Completed
Chattanooga Women for WomenHixson, 37343, United States
Completed
Discovery Clinical TrialsDallas, 75231, United States
Completed
Vital Pharma ResearchHialeah, 33016, United States
Completed
Discovery Clinical TrialsSan Antonio, 78258, United States
Completed
Medical Center for Clinical ResearchSan Diego, 92108, United States
Completed
Health Awareness, Inc.Jupiter, 33458, United States
Completed
A Premier Medical Research of Florida, LLCOrange City, 32763, United States
Completed
Artemis Institute for Clinical ResearchSan Diego, 92103, United States
Withdrawn
Cleveland ClinicCleveland, 44195, United States
Withdrawn
Amy Brenner, MD & Associates, LLCMason, 45040, United States
Completed
Gynekologicka ambulance - Zabreh na MoraveZabreh na Morave, 78901, Czechia
Completed
Gynekologie MUDr. Jaromir Karban s.r.oNeratovice, 277 11, Czechia
Completed
Privatni gynekologicko-porodnicka ordinacePraha, 16000, Czechia
Completed
GYNEVI s.r.o.Rokycany, 337 01, Czechia
Completed
GynPorCentrum s.r.o.Krnov, 794 01, Czechia
Completed
Center of Reproductive MedicineWebster, 77598, United States
Withdrawn
Northwestern UniversityChicago, 60611, United States
Completed
Suncoast Research Group, LLCMiami, 33135, United States
Completed
Tidewater Physicians for WomenNorfolk, 23502, United States
Completed
Oregon Health and Science UniversityPortland, 97239-3011, United States
Completed
Genoma Research Group, Inc.Miami, 33165, United States
Completed
South Florida Clinical Research InstituteMargate, 33073, United States
Completed
Florida Research Center, Inc.Miami, 33174, United States
Completed
Advanced Pharma CR, LLCMiami, 33147, United States
Completed
National Research InstituteHuntington Park, 90255, United States
Completed
Gadolin ResearchBeaumont, 77702, United States
Completed
West Coast OB/GYN AssociatesLA Mesa, 91942, United States
Completed
Smolensk State Medical UniversitySmolensk, 214019, Russian Federation
Withdrawn
Regional Clinical Hospital #2Krasnodar, 350012, Russian Federation
Completed
Med Estetic CenterSt. Petersburg, 192177, Russian Federation
Completed
Close Joint Stock Company "Medical Company IDK"Samara, 443067, Russian Federation
Completed
Maternity Hospital, 17Saint-Petersburg, 192174, Russian Federation
Completed
"Granti-Med"St. Petersburg, 198329, Russian Federation
Completed
Scien. Res. Institute of Obsterics, Gyn. & ReproductionSt. Petersburg, 199034, Russian Federation
Completed
Altai State Medical UniversityBarnaul, 656038, Russian Federation
Completed
Vinnytsia City Clinical Maternity Hospital No 2Vinnytsia, 21001, Ukraine
Completed
Chernivtsi Regional Perinatal CenterChernivtsi, 58001, Ukraine
Completed
Zaporizhzhia Regional Clinical HospitalZaporizhzhya, 69103, Ukraine
Withdrawn
Spitalul Clinic Nicolae MalaxaBucuresti, 022448, Romania
Withdrawn
S.C. Centrul Medical Euromed S.R.LBucuresti, 020762, Romania
Withdrawn
S.C. Quantum Medical Center S.R.LBucuresti, 012071, Romania
Withdrawn
S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRLBrasov, 500283, Romania
Withdrawn
S.C. SANADOR SRLBucharest, 011026, Romania
Withdrawn
Spitalul Clinic Municipal Filantropia CraiovaCraiova, 200143, Romania
Completed
National Research InstitutePanorama City, 91402, United States
Completed
Hashimoto ClinicSapporo, 004-0052, Japan
Completed
Yoshio ClinicSapporo, 064-0808, Japan
Completed
Tokeidai Memorial ClinicSapporo, 060-0031, Japan
Completed
Medical Topia Soka HospitalSoka, 340-0028, Japan
Completed
Ena Odori ClinicSapporo, 060-0001, Japan
Completed
Kagawa Prefectural Central HospitalTakamatsu, 760-8557, Japan
Completed
Unoki ClinicKagoshima, 892-0826, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
Asahi-Clinic.Takamatsu, 760-0076, Japan
Completed
Kyoto city HospitalNakagyo-ku, 604-8845, Japan
Completed
Takamatsu Red Cross HospitalTakamatsu, 760-0017, Japan
Completed
Gokeikai Osaka Kaisei HospitalOsaka, 532-0003, Japan
Completed
Tetsu-Nakamura Obstetrics and Gynecology Internal MedicineKagoshima, 892-0845, Japan
Completed
Matsudo City General HospitalMatsudo, 270-2296, Japan
Completed
Osaka City Hospital Organization Osaka City General HospitalOsaka, 534-0021, Japan
Completed
Ijinkai Takeda General HospitalKyoto, 601-1495, Japan
Completed
Tsujinaka Hospital KashiwanohaKashiwa, 277-0871, Japan
Completed
Medical Co. LEADING GIRLS Women's Clinic LUNA ShinsaibashiOsaka, 542-0086, Japan
Completed
FOUR SEASONS LADIES’ CLINICKumamoto, 860-0846, Japan
Completed
Funabashi Municipal Medical CenterFunabashi, 273-8588, Japan
Completed
Saiseikai Fukuoka General HospitalFukuoka, 810-0001, Japan
Completed
Shonan Fujisawa Tokushukai HospitalFujisawa, 251-0041, Japan
Completed
OMI MEDICAL CENTERKusatsu, 525-8585, Japan
Completed
Women Partners in Health Obstetrics & Gynecology (OB/GYN)Austin, 78705, United States
Withdrawn
Central Research Associates, Inc.Birmingham, 35205, United States
Completed
Kobe City Medical Center General HospitalKobe, 650-0047, Japan
Completed
Kosumo ClinicKako-gun, 675-1115, Japan
Withdrawn
Nash OB-GYN Associates, P.A.Rocky Mount, 27804, United States
Completed
Japanese Red Cross Kyoto Daini HospitalKyoto, 602-8026, Japan
Withdrawn
Great Lakes Research Group, Inc.Saginaw, 48602, United States
Withdrawn
United Clinical ResearchHuntington Beach, 90255, United States
Withdrawn
Gynekologie MEDA s.r.o.Brno, 602 00, Czechia

Primary Outcome

  • 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.
    date_rangeTime Frame:
    The last 28 days of treatment period 1

Secondary Outcome

  • 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).
    date_rangeTime Frame:
    The last 28 days of treatment period 1 and treatment period 2
  • 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).
    date_rangeTime Frame:
    In treatment period 1 (12 weeks) and in treatment period 2 (12 weeks)
  • 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).
    date_rangeTime Frame:
    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).
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    Up to 36 weeks
  • 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.
    date_rangeTime Frame:
    Up to 36 weeks

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

Additional Information

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