Trial Condition(s):
pharmacodynamics
Pharmacodynamic characterization of Dienogest
Bayer Identifier:
13180
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox B.V. Groningen, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A double-blind, randomized, dose-controlled study to evaluate pharmacodynamic properties of four oral doses of dienogest (DNG) in 100 healthy young female volunteers over a period of two cycles up to a maximum of 72 days
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis plannedTimeframe: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
Secondary Outcome
- Course of gonadotropins (FSH, LH, P, E2)Timeframe: During pre-treatment and treatment cycles (3 months)
- Endometrial thicknessTimeframe: During pre-treatment and treatment cycles (3 months)
- Grading of ovarian activityTimeframe: During pre-treatment and treatment cycles (3 months)
- Effects on the cervix and the cervical mucusTimeframe: During pre-treatment and treatment cycles (3 months)
- mRNA expression profile of endometrial biopsies and in bloodTimeframe: once in pre-treatment and during treatment
- Concentrations of DNG in serumTimeframe: During pre-treatment and treatment cycles (3 months)
- Safety and tolerabilityTimeframe: During pre-treatment and treatment cycles (3 months)
Additional Information
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