Pharmacodynamic Characterization of Dienogest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-09-30

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.

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Detailed Description

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Conditions

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Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Dienogest (81150037)

Intervention Type DRUG

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

Arm 2

Group Type EXPERIMENTAL

Dienogest (81150231)

Intervention Type DRUG

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

Arm 3

Group Type EXPERIMENTAL

Dienogest (SH T00660A)

Intervention Type DRUG

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

Arm 4

Group Type EXPERIMENTAL

Dienogest (81150746)

Intervention Type DRUG

daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Interventions

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Dienogest (81150037)

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

Intervention Type DRUG

Dienogest (81150231)

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

Intervention Type DRUG

Dienogest (SH T00660A)

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

Intervention Type DRUG

Dienogest (81150746)

daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes