stop_circleTerminated/Withdrawn

Uterine fibroids

Bayer Identifier:

19434

ClinicalTrials.gov Identifier:

NCT03699176

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of safety and efficacy of vilaprisan in subjects with uterine fibroids

Trial purpose

The primary objective of this study is 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 are 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 at the time of Visit 1
    - Diagnosis of uterine fibroid(s) documented by ultrasound at screening with at least 1 fibroid with largest diameter of ≥ 30 mm (alternatively, of 30 mm or more)
    - 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 menstrual pictogram (MP)
    - Use of an acceptable non-hormonal method of contraception
    - An endometrial biopsy performed during the screening period, without significant histological disorder such as endometrial hyperplasia (including simple hyperplasia) or other significant endometrial pathology
  • - Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
    - Hypersensitivity to any ingredient of the study drugs
    - 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 including
    - Abuse of alcohol, drugs, or medicines (eg: laxatives)
    - Undiagnosed abnormal genital bleeding
    - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

Trial summary

Enrollment Goal
0
Trial Dates
October 2018 - December 2019
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Ingenuity HouseUmhlanga, 4321, South Africa
Withdrawn
Panaroma Medical CentreCape Town, 7500, South Africa
Withdrawn
Vincent Pallotti HospitalCape Town, 7450, South Africa
Withdrawn
University of Pretoria, Clinical Research UnitPretoria, 0002, South Africa
Withdrawn
Durban International Clinical Research SiteDurban, 4052, South Africa
Withdrawn
University of Cape Town Clinical Research CentreCape Town, 7925, South Africa
Withdrawn
Farmovs-ParexelBloemfontein, 9301, South Africa
Withdrawn
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Withdrawn
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma HastAnkara, Turkey
Withdrawn
I.S.B. Uni. Kanuni Sultan Suleyman Egitim ve Aras. Hast.Istanbul, 34303, Turkey
Withdrawn
Trakya Univ. Tip Fak.Edirne, 22030, Turkey
Withdrawn
Baskent Universitesi Tip Fakultesi HastanesiAnkara, 6490, Turkey
Withdrawn
Dokuz Eylul Universitesi Tip FakultesiIzmir, 35340, Turkey
Withdrawn
Clinical Hospital #122 n.a. L.G. SokolovSt. Petersburg, 194291, Russian Federation
Withdrawn
Endocrinology Scientific CentreMoscow, 117036, Russian Federation
Withdrawn
Kazan Federal UniversityKazan, 420008, Russian Federation
Withdrawn
Krasnoyarsk State Medical UniversityKrasnoyarsk, 660022, Russian Federation
Withdrawn
Regional perinatal centerYaroslavl, 150042, Russian Federation
Withdrawn
City Clinical Hospital #13Moscow, 115280, Russian Federation
Withdrawn
Iizuka HospitalIizuka, 820-8505, Japan
Completed
Ena Odori ClinicSapporo, 060-0001, Japan
Completed
Unoki ClinicKagoshima, 892-0826, Japan
Withdrawn
Kyoto city HospitalNakagyo-ku, 604-8845, Japan
Withdrawn
Gokeikai Osaka Kaisei HospitalOsaka, 532-0003, Japan
Withdrawn
Tonan HospitalSapporo, 060-0004, Japan
Withdrawn
Shiga General HospitalMoriyama, 524-8524, Japan
Completed
Tokeidai Memorial ClinicSapporo, 060-0031, Japan
Completed
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
Asahi clinicTakamatsu, 760-0076, Japan
Completed
Matsudo City General HospitalMatsudo, 270-2296, Japan
Withdrawn
FOUR SEASONS LADIES’ CLINICKumamoto, 860-0846, Japan
Completed
Funabashi Municipal Medical CenterFunabashi, 273-8588, Japan
Completed
Kagawa Prefectural Central HospitalTakamatsu, 760-8557, Japan
Withdrawn
Takamatsu Red Cross HospitalTakamatsu, 760-0017, Japan
Withdrawn
Kusatsu General HospitalKusatsu, 525-8585, Japan
Withdrawn
Kashiwazaki ladies clinicSaitama, 330-0855, Japan
Withdrawn
Japanese Red Cross Kyoto Daini HospitalKyoto, 602-8026, Japan
Withdrawn
Tsujinaka Hospital KashiwanohaKashiwa, 277-0871, Japan

Primary Outcome

  • Amenorrhea (yes/no)
    Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)
    date_rangeTime Frame:
    Up to 24 weeks (The last 28 days of treatment period 2)

Secondary Outcome

  • Heavy menstrual bleeding (HMB) response (yes/no)
    Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline
    date_rangeTime Frame:
    Up to 24 weeks (the last 28 days of treatment period 2)
  • Time to onset of amenorrhea
    Onset of amenorrhea is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <2mL.
    date_rangeTime Frame:
    Up to 24 weeks
  • Time to onset of controlled bleeding
    Onset of controlled bleeding is defined by the first day for which the menstrual blood loss for all subsequent 28-day periods up to the end of the treatment period is <80.00 mL.
    date_rangeTime Frame:
    Up to 24 weeks
  • Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)
    date_rangeTime Frame:
    Up to 24 weeks (the last 28 days of treatment period 2)
  • Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)
    date_rangeTime Frame:
    Up to 36 weeks
  • Endometrial thickness
    date_rangeTime Frame:
    Up to 36 weeks

Trial design

A randomized, parallel-group, double-blind 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
2

Additional Information

Click here to find out more about the study and how to participate