Pharmacodynamic Characterization of Dienogest

Phase 1

Completed

• Conditions: Pharmacodynamics
• Interventions: Drug: Dienogest (81150231); Drug: Dienogest (SH T00660A); Drug: Dienogest (81150037); Drug: Dienogest (81150746)

• Registration Number: NCT00754871
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2009-07
• Study Completion: 2009-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Dienogest (81150231)	-
Arm 3	Dienogest (SH T00660A)	-
Arm 1	Dienogest (81150037)	-
Arm 4	Dienogest (81150746)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Concentrations of DNG in serum	During pre-treatment and treatment cycles (3 months)
Endometrial thickness	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)
mRNA expression profile of endometrial biopsies and in blood	once in pre-treatment and during treatment
Safety and tolerability	During pre-treatment and treatment cycles (3 months)
Grading of ovarian activity	During pre-treatment and treatment cycles (3 months)