stop_circleTerminated/Withdrawn
Uterine fibroids
Bayer Identifier:
19434
ClinicalTrials.gov Identifier:
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
FemaleAge
18 - N/ATrial summary
Enrollment Goal
0Trial Dates
October 2018 - December 2019Phase
Phase 3Could I Receive a placebo
YesProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Ingenuity House | Umhlanga, 4321, South Africa |
Withdrawn | Panaroma Medical Centre | Cape Town, 7500, South Africa |
Withdrawn | Vincent Pallotti Hospital | Cape Town, 7450, South Africa |
Withdrawn | University of Pretoria, Clinical Research Unit | Pretoria, 0002, South Africa |
Withdrawn | Durban International Clinical Research Site | Durban, 4052, South Africa |
Withdrawn | University of Cape Town Clinical Research Centre | Cape Town, 7925, South Africa |
Withdrawn | Farmovs-Parexel | Bloemfontein, 9301, South Africa |
Withdrawn | Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi | Istanbul, 34098, Turkey |
Withdrawn | Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast | Ankara, Turkey |
Withdrawn | I.S.B. Uni.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Withdrawn | Trakya Univ.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Withdrawn | Baskent Universitesi Tip Fakultesi Hastanesi | Ankara, 6490, Turkey |
Withdrawn | Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35340, Turkey |
Withdrawn | Clinical Hospital #122 n.a. L.G. Sokolov | St. Petersburg, 194291, Russian Federation |
Withdrawn | Endocrinology Scientific Centre | Moscow, 117036, Russian Federation |
Withdrawn | Kazan Federal University | Kazan, 420008, Russian Federation |
Withdrawn | Krasnoyarsk State Medical University | Krasnoyarsk, 660022, Russian Federation |
Withdrawn | Regional perinatal center | Yaroslavl, 150042, Russian Federation |
Withdrawn | City Clinical Hospital #13 | Moscow, 115280, Russian Federation |
Withdrawn | Iizuka Hospital | Iizuka, 820-8505, Japan |
Completed | Ena Odori Clinic | Sapporo, 060-0001, Japan |
Completed | Unoki Clinic | Kagoshima, 892-0826, Japan |
Withdrawn | Kyoto city Hospital | Nakagyo-ku, 604-8845, Japan |
Withdrawn | Gokeikai Osaka Kaisei Hospital | Osaka, 532-0003, Japan |
Withdrawn | Tonan Hospital | Sapporo, 060-0004, Japan |
Withdrawn | Shiga General Hospital | Moriyama, 524-8524, Japan |
Completed | Tokeidai Memorial Clinic | Sapporo, 060-0031, Japan |
Completed | Japanese Red Cross Kumamoto Hospital | Kumamoto, 861-8520, Japan |
Completed | Asahi clinic | Takamatsu, 760-0076, Japan |
Completed | Matsudo City General Hospital | Matsudo, 270-2296, Japan |
Withdrawn | FOUR SEASONS LADIES’ CLINIC | Kumamoto, 860-0846, Japan |
Completed | Funabashi Municipal Medical Center | Funabashi, 273-8588, Japan |
Completed | Kagawa Prefectural Central Hospital | Takamatsu, 760-8557, Japan |
Withdrawn | Takamatsu Red Cross Hospital | Takamatsu, 760-0017, Japan |
Withdrawn | Kusatsu General Hospital | Kusatsu, 525-8585, Japan |
Withdrawn | Kashiwazaki ladies clinic | Saitama, 330-0855, Japan |
Withdrawn | Japanese Red Cross Kyoto Daini Hospital | Kyoto, 602-8026, Japan |
Withdrawn | Tsujinaka Hospital Kashiwanoha | Kashiwa, 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 baselinedate_rangeTime Frame:Up to 24 weeks (the last 28 days of treatment period 2)
- Time to onset of amenorrheaOnset 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 bleedingOnset 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 thicknessdate_rangeTime Frame:Up to 36 weeks
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2