Pharmacodynamic Characterization of Dienogest

Bayer102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

102

Conditions

Pharmacodynamics

Interventions

Dienogest (81150037)DRUG

daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days

Dienogest (81150231)DRUG

daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days

Dienogest (SH T00660A)DRUG

daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Groningen, Netherlands

Outcomes

Primary Outcomes

No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned

Time frame: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned