Pharmacodynamic Characterization of Dienogest

Pharmacodynamics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754871
• Other study ID #: 13180
• Secondary ID: 2008-003611-13
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2008
• Last updated: January 26, 2015
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pharmacodynamics

Intervention

Drug:
• Dienogest (81150037)
daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
• Dienogest (81150231)
daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
• Dienogest (SH T00660A)
daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
• Dienogest (81150746)
daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Course of gonadotropins (FSH, LH, P, E2)		During pre-treatment and treatment cycles (3 months)	No
Secondary	Endometrial thickness		During pre-treatment and treatment cycles (3 months)	No
Secondary	Grading of ovarian activity		During pre-treatment and treatment cycles (3 months)	No
Secondary	Effects on the cervix and the cervical mucus		During pre-treatment and treatment cycles (3 months)	No
Secondary	mRNA expression profile of endometrial biopsies and in blood		once in pre-treatment and during treatment	No
Secondary	Concentrations of DNG in serum		During pre-treatment and treatment cycles (3 months)	No
Secondary	Safety and tolerability		During pre-treatment and treatment cycles (3 months)	No

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