Pharmacodynamic Characterization of Dienogest

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacodynamics

Treatments: Drug: Dienogest (81150746); Drug: Dienogest (81150231); Drug: Dienogest (SH T00660A); Drug: Dienogest (81150037)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754871

13180

2008-003611-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

102 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: Dienogest (81150037)

Arm 2

Experimental group

Treatment:

Drug: Dienogest (81150231)

Arm 3

Experimental group

Treatment:

Drug: Dienogest (SH T00660A)

Arm 4

Experimental group

Treatment:

Drug: Dienogest (81150746)