Pharmacodynamics
Conditions
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 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.
Interventions
DRUGDienogest (81150037)
daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
DRUGDienogest (81150231)
daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
DRUGDienogest (SH T00660A)
daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
DRUGDienogest (81150746)
daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned | No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned |
Secondary
| Measure | Time frame |
|---|---|
| Endometrial thickness | During pre-treatment and treatment cycles (3 months) |
| Grading of ovarian activity | During pre-treatment and treatment cycles (3 months) |
| Effects on the cervix and the cervical mucus | During pre-treatment and treatment cycles (3 months) |
| Course of gonadotropins (FSH, LH, P, E2) | During pre-treatment and treatment cycles (3 months) |
| Concentrations of DNG in serum | During pre-treatment and treatment cycles (3 months) |
| Safety and tolerability | During pre-treatment and treatment cycles (3 months) |
| mRNA expression profile of endometrial biopsies and in blood | once in pre-treatment and during treatment |
Countries
Netherlands
Outcome results
None listed