Trial Condition(s):

pharmacodynamics

Pharmacodynamic characterization of Dienogest

Bayer Identifier:

13180

ClinicalTrials.gov Identifier:

NCT00754871

EudraCT Number:

2008-003611-13

Study Completed

Trial Purpose

This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.

Inclusion Criteria
- Signed informed consent
 - Body-Mass-Index (BMI): 18 - 30 kg/m² 
 - Healthy female volunteers
 - Age 18-35 years (smoker not older than 30 years, inclusive)
 - At least 3 months since delivery, abortion or lactation
 - Willingness to use non-hormonal methods of contraception during entire study
Exclusion Criteria
- Contraindications for use of progesterone-only pills or combined oral contraceptives (e.g. history of venous/arterial thromboembolic disease)
 - Use of systemic or topical medications or substances which oppose the study objectives or which might influence them within 4 weeks prior to start of the pre-treatment cycle 
 - Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)

Trial Summary

Enrollment Goal
102
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dinox B.V.

Groningen, Netherlands, 9713 GZ

Status
Completed
 

Trial Design