Status:
COMPLETED
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
Lead Sponsor:
Bayer
Conditions:
Leiomyoma
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
Effects of BAY1002670 on bleeding pattern: non-bleeding rate; on endometrium; on ovarian function; return of menstrual bleeding after treatment; safety and tolerability; PK/PD (pharmacokinetic/pharmac...
Eligibility Criteria
Inclusion
- Healthy female subjects
- 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
- Regular use of medicines (incl. anabolics)
- 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)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01816815
Start Date
November 1 2011
End Date
January 1 2013
Last Update
April 21 2014
Active Locations (6)
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1
Antwerp, Belgium, 2060
2
Neu-Ulm, Bavaria, Germany, 89231
3
Neuss, North Rhine-Westphalia, Germany, 41450
4
Berlin, State of Berlin, Germany, 10117