check_circleStudy Completed

Leiomyoma

Bayer Identifier:

14723

ClinicalTrials.gov Identifier:

NCT01816815

EudraCT Number:

2011-001760-22

EU CT Number:

Not Available
Study in healthy tubal ligated women to evaluate pharmacodynamics, safety and pharmacokinetics of BAY1002670

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

Key Participants Requirements

Sex

Female

Age

18 - 45 Years
  • - 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
  • - 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
73
Trial Dates
November 2011 - January 2013
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Pharma AGBerlin, 13353, Germany
Completed
Nuvisan GmbHNeu-Ulm, 89231, Germany
Completed
Focus Clinical Drug Development GmbHNeuss, 41450, Germany
Completed
BioKinetic Europe LtdBelfast, BT2 7BA, United Kingdom
Completed
ZNA StuivenbergANTWERPEN, 2060, Belgium
Completed
Charité Research Organisation GmbHBerlin, 10117, Germany

Primary Outcome

  • Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)
    date_rangeTime Frame:
    After three months
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    Safety Issue:
    No

Secondary Outcome

  • Return of menstrual bleeding after treatment
    date_rangeTime Frame:
    Up to two months after last treatment
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    Safety Issue:
    No

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

Additional Information

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