Trial Condition(s):
Leiomyoma
Study in healthy tubal ligated women to evaluate pharmacodynamics, safety and pharmacokinetics of BAY1002670
Bayer Identifier:
14723
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Bayer Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nuvisan GmbH Neu-Ulm, Germany, 89231 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Focus Clinical Drug Development GmbH Neuss, Germany, 41450 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations BioKinetic Europe Ltd Belfast, United Kingdom, BT2 7BA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Stuivenberg ANTWERPEN, Belgium, 2060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Research Organisation GmbH Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A multi-center, randomized, double-blind, placebo-controlled, parallel group study in 60 healthy tubal-ligated women aged 18 to 45 years investigating the pharmacodynamic effects of 5 different doses (0.1 – 5 mg) BAY1002670 after daily oral administration over 84 days
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)Timeframe: After three months
Secondary Outcome
- Return of menstrual bleeding after treatmentTimeframe: Up to two months after last treatment
Additional Information
Copyright © Bayer
Powered by
