Study in Healthy Young Women to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of Vilaprisan
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ClinicalTrials.gov Identifier: NCT02262663 |
Recruitment Status :
Completed
First Posted : October 13, 2014
Last Update Posted : March 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clinical Trial, Phase I | Drug: Vilaprisan (BAY1002670) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Official Title: | A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety After Daily Oral Administration of 4 Different Doses of Vilaprisan (BAY1002670) in Healthy Women of Reproductive Age |
Study Start Date : | October 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Vilaprisan [0.5mg]
0.5 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
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Drug: Vilaprisan (BAY1002670) |
Experimental: Vilaprisan [1mg]
1 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
|
Drug: Vilaprisan (BAY1002670) |
Experimental: Vilaprisan [2mg]
2 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
|
Drug: Vilaprisan (BAY1002670) |
Experimental: Vilaprisan [4mg]
4 mg BAY1002670, oral administration, one tablet to be taken daily, 84 consecutive days
|
Drug: Vilaprisan (BAY1002670) |
- Hoogland score during treatment, day 9 to day 28 [ Time Frame: Day 9 to 28 ]based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
- Hoogland score during treatment, day 63 to day 84 [ Time Frame: Day 63 to 84 ]based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
- Hoogland score during follow up cycle 1 [ Time Frame: 4 weeks following treatment period ]based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
- Hoogland score during follow up cycle 2 [ Time Frame: 4 weeks following follow up cycle 1 ]based on maximum size of follicle-like structures, estradiol and progesterone serum concentrations
- Number of subjects without bleeding/spotting [ Time Frame: After three month treatment ]
- Exposure-response analysis of vilaprisan by population pharmacokinetic/pharmacodynamic modeling [ Time Frame: After three month treatment ]
- Number of subjects with TEAEs (treatment-emergent adverse events) [ Time Frame: After three month treatment and during follow-up (up to 60 days) ]
- Number of subjects with PAEC (progesterone-receptor-modulator associated endometrial changes) [ Time Frame: After three month treatment and during follow-up (up to 60 days) ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Body mass index (BMI): ≥ 18 and ≤ 32 kg/m² at the first screening visit
- Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
- Pre-treatment cycle assessed as ovulatory and not longer than 44 days
Exclusion Criteria:
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination or effects of the study drugs will not be normal
- Known or suspected liver disorders
- Amenorrhea for more than 3 months within the last 6 months before the first screening examination
- Clinically relevant findings (e.g. blood pressure, electrocardiogram [ECG], physical and gynecological examination, laboratory examination)
- Positive urine pregnancy test
- Regular use of medicines

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): NCT02262663
Germany | |
Berlin, Germany, 10115 | |
Berlin, Germany, 13353 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT02262663 |
Other Study ID Numbers: |
15818 2014-000329-19 ( EudraCT Number ) |
First Posted: | October 13, 2014 Key Record Dates |
Last Update Posted: | March 16, 2016 |
Last Verified: | March 2016 |