Trial Condition(s):
Uterine Fibroids
Assessment of safety and efficacy of vilaprisan in subjects with uterine fibroids (ASTEROID 7)
Bayer Identifier:
19434
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
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 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Ingenuity House Umhlanga, South Africa, 4321 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Panaroma Medical Centre Cape Town, South Africa, 7500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vincent Pallotti Hospital Cape Town, South Africa, 7450 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pretoria, Clinical Research Unit Pretoria, South Africa, 0002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Durban International Clinical Research Site Durban, South Africa, 4052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Cape Town Clinical Research Centre Cape Town, South Africa, 7925 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Farmovs-Parexel Bloemfontein, South Africa, 9301 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Etlik Zubeyde Hanim Kadin Hastaliklari Egitim Arastirma Hast Ankara, Turkey | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations I.S.B. Uni. Kanuni Sultan Suleyman Egitim ve Aras. Hast. Istanbul, Turkey, 34303 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trakya Univ. Tip Fak. Edirne, Turkey, 22030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Baskent Universitesi Tip Fakultesi Hastanesi Ankara, Turkey, 06490 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dokuz Eylul Universitesi Tip Fakultesi Izmir, Turkey, 35340 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Hospital #122 n.a. L.G. Sokolov St. Petersburg, Russia, 194291 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Endocrinology Scientific Centre Moscow, Russia, 117036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional perinatal center Yaroslavl, Russia, 150042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #13 Moscow, Russia, 115280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Iizuka Hospital Iizuka, Japan, 820-8505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ena Odori Clinic Sapporo, Japan, 060-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Unoki Clinic Kagoshima, Japan, 892-0826 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto city Hospital Nakagyo-ku, Japan, 604-8845 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gokeikai Osaka Kaisei Hospital Osaka, Japan, 532-0003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tonan Hospital Sapporo, Japan, 060-0004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shiga General Hospital Moriyama, Japan, 524-8524 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokeidai Memorial Clinic Sapporo, Japan, 060-0031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asahi clinic Takamatsu, Japan, 760-0076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Matsudo City General Hospital Matsudo, Japan, 270-2296 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FOUR SEASONS LADIES’ CLINIC Kumamoto, Japan, 860-0846 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Funabashi Municipal Medical Center Funabashi, Japan, 273-8588 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kagawa Prefectural Central Hospital Takamatsu, Japan, 760-8557 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Takamatsu Red Cross Hospital Takamatsu, Japan, 760-0017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kusatsu General Hospital Kusatsu, Japan, 525-8585 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kashiwazaki ladies clinic Saitama, Japan, 330-0855 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto Second Red Cross Hospital Kyoto, Japan, 602-8026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tsujinaka Hospital Kashiwanoha Kashiwa, Japan, 277-0871 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Amenorrhea (yes/no)Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)Timeframe: 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 baselineTimeframe: 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.Timeframe: 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.Timeframe: Up to 24 weeks
- Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD)Timeframe: Up to 24 weeks (the last 28 days of treatment period 2)
- Endometrial histology (eg, benign endometrium, presence or absence of hyperplasia or malignancy)Timeframe: Up to 36 weeks
- Endometrial thicknessTimeframe: Up to 36 weeks
Additional Information
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