Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
NCT ID: NCT01816815
Last Updated: 2014-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2011-11-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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BAY1002670 [0.1mg]
0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670
BAY1002670 [0.5mg]
0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670
BAY1002670 [1.0mg]
1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670
BAY1002670 [2.0mg]
2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670
BAY1002670 [5.0mg]
5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
BAY1002670
Placebo
Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days
Placebo
Interventions
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BAY1002670
Placebo
Eligibility Criteria
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Inclusion Criteria
* Sterilized by tubal ligation
* Age 18-45 years
* Body mass index (BMI) at screening: ≥ 18 and ≤ 32 kg/m²
* At least 3 consecutive regular menstrual cycles with a cycle length of 24 - 35 days before first screening examination according to the subject's history
* Absence of clinically relevant abnormal findings in the pre-treatment endometrial biopsy
Exclusion Criteria
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Amenorrhea for more than 3 months within the last 6 months before the first screening examination
* Lacking suitability for frequent transvaginal ultrasonography (TVU) examinations
* Clinically relevant findings (e.g. blood pressure, electrocardiogram \[ECG\], physical and gynecological examination, laboratory examination)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Antwerp, , Belgium
Neu-Ulm, Bavaria, Germany
Neuss, North Rhine-Westphalia, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Belfast, Belfast, United Kingdom
Countries
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References
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Schutt B, Kaiser A, Schultze-Mosgau MH, Seitz C, Bell D, Koch M, Rohde B. Pharmacodynamics and safety of the novel selective progesterone receptor modulator vilaprisan: a double-blind, randomized, placebo-controlled phase 1 trial in healthy women. Hum Reprod. 2016 Aug;31(8):1703-12. doi: 10.1093/humrep/dew140. Epub 2016 Jun 10.
Other Identifiers
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2011-001760-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14723
Identifier Type: -
Identifier Source: org_study_id
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