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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


Phase 1
18 Years
45 Years
Not Enrolling
Female
Leiomyoma

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Outcome Measure:

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

Outcome Time Frame:

After three months

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

14723

NCT ID:

NCT01816815

Start Date:

November 2011

Completion Date:

January 2013

Related Keywords:

  • Leiomyoma
  • PK/PD
  • BAY1002670
  • Leiomyoma
  • Myofibroma

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