Pharmacodynamic Characterization of Dienogest

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacodynamics

Intervention / Treatment
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* Drug: Dienogest (81150037)
* Drug: Dienogest (81150231)
* Drug: Dienogest (SH T00660A)
* Drug: Dienogest (81150746)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Dienogest (81150037)<br>* daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days<br>|
| Experimental: Arm 2<br> | Drug: Dienogest (81150231)<br>* daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days<br>|
| Experimental: Arm 3<br> | Drug: Dienogest (SH T00660A)<br>* daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days<br>|
| Experimental: Arm 4<br> | Drug: Dienogest (81150746)<br>* daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of gonadotropins (FSH, LH, P, E2) |  | During pre-treatment and treatment cycles (3 months) | 
| 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) | 
| mRNA expression profile of endometrial biopsies and in blood |  | once in pre-treatment and during treatment | 
| Concentrations of DNG in serum |  | During pre-treatment and treatment cycles (3 months) | 
| Safety and tolerability |  | During pre-treatment and treatment cycles (3 months) |