Status:
COMPLETED
Pharmacodynamic Characterization of Dienogest
Lead Sponsor:
Bayer
Conditions:
Pharmacodynamics
Eligibility:
FEMALE
18-35 years
Phase:
PHASE1
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00754871
Start Date
September 1 2008
End Date
September 1 2009
Last Update
January 27 2015
Active Locations (1)
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1
Groningen, Netherlands, 9713 GZ