Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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/pharmacodynamic) relationship

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)