Leiomyoma
Conditions
Keywords
PK/PD, BAY1002670
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/pharmacodynamic) relationship
Interventions
DRUGBAY1002670
DRUGPlacebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment) | After three months |
Secondary
| Measure | Time frame |
|---|---|
| Return of menstrual bleeding after treatment | Up to two months after last treatment |
Countries
Belgium, Germany, United Kingdom
Outcome results
None listed