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

Leiomyoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816815
• Other study ID #: 14723
• Secondary ID: 2011-001760-22
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2013
• Last updated: April 18, 2014
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• BAY1002670

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-bleeding rate (i.e. women without bleeding from treatment day 9 until the end of treatment)		After three months	No
Secondary	Return of menstrual bleeding after treatment		Up to two months after last treatment	No

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