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

Bayer

Status and phase: Completed; Phase 1

Conditions: Leiomyoma

Treatments: Drug: Placebo; Drug: BAY1002670

Study type: Interventional

Funder types: Industry

Identifiers

NCT01816815

2011-001760-22 (EudraCT Number)

14723

Details and patient eligibility

About

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

Enrollment: 73 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

73 participants in 6 patient groups, including a placebo group

BAY1002670 [0.1mg]

Experimental group

Description:

0.1 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: BAY1002670

BAY1002670 [0.5mg]

Experimental group

Description:

0.5 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: BAY1002670

BAY1002670 [1.0mg]

Experimental group

Description:

1.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: BAY1002670

BAY1002670 [2.0mg]

Experimental group

Description:

2.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: BAY1002670

BAY1002670 [5.0mg]

Experimental group

Description:

5.0 mg BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: BAY1002670

Placebo

Placebo Comparator group

Description:

Placebo for BAY1002670, oral administration, four tablets to be taken daily, 84 consecutive days

Treatment:

Drug: Placebo