Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 7)
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ClinicalTrials.gov Identifier: NCT03699176 |
Recruitment Status :
Withdrawn
(No patient was recruited, study withdrawn for feasibility reasons.)
First Posted : October 9, 2018
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Fibroids | Drug: Vilaprisan (BAY1002670) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Parallel-group, Double-blind Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Vilaprisan in Subjects With Uterine Fibroids |
Actual Study Start Date : | October 27, 2018 |
Actual Primary Completion Date : | December 25, 2019 |
Actual Study Completion Date : | December 25, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Vilaprisan
2 treatment periods of 12 weeks without a break
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Drug: Vilaprisan (BAY1002670)
2 mg, once daily, oral |
Placebo Comparator: Placebo
2 treatment periods of 12 weeks without a break
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Drug: Placebo
Once daily, oral |
- Amenorrhea (yes/no) [ Time Frame: Up to 24 weeks (The last 28 days of treatment period 2) ]Defined as menstrual blood loss (MBL) <2 mL (based on menstrual pictogram)
- Heavy menstrual bleeding (HMB) response (yes/no) [ Time Frame: Up to 24 weeks (the last 28 days of treatment period 2) ]Defined as blood loss <80.00 mL during the last 28 days of treatment and >50% reduction compared to baseline
- Time to onset of amenorrhea [ Time Frame: Up to 24 weeks ]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.
- Time to onset of controlled bleeding [ Time Frame: Up to 24 weeks ]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.
- Absence of bleeding (spotting allowed) based on the Uterine Fibroid Daily Bleeding Diary (UF-DBD) [ Time 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) [ Time Frame: Up to 36 weeks ]
- Endometrial thickness [ Time Frame: Up to 36 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699176
Japan | |
Funabashi Municipal Medical Center | |
Funabashi, Chiba, Japan, 273-8588 | |
Matsudo City General Hospital | |
Matsudo, Chiba, Japan, 270-2296 | |
Ena Odori Clinic | |
Sapporo, Hokkaido, Japan, 060-0001 | |
Tokeidai Memorial Clinic | |
Sapporo, Hokkaido, Japan, 060-0031 | |
Asahi clinic | |
Takamatsu, Kagawa, Japan, 760-0076 | |
Kagawa Prefectural Central Hospital | |
Takamatsu, Kagawa, Japan, 760-8557 | |
Unoki Clinic | |
Kagoshima, Japan, 892-0826 | |
Japanese Red Cross Kumamoto Hospital | |
Kumamoto, Japan, 861-8520 |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT03699176 |
Other Study ID Numbers: |
19434 |
First Posted: | October 9, 2018 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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