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Completed

NCT Number: NCT01816815

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

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

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Key information

Conditions

Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BAY1002670

Drug

Placebo

Drug

Primary outcomes

  1. Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)

    Time frame: After three months

Secondary outcomes

  1. Return of menstrual bleeding after treatment

    Time frame: Up to two months after last treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 22, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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