Pharmacodynamic Characterization of Dienogest

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacodynamics
• Intervention / Treatment: Drug: Dienogest (81150037); Drug: Dienogest (81150231); Drug: Dienogest (SH T00660A); Drug: Dienogest (81150746)

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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: 10.1177/0091270011423664. Epub 2011 Nov 29.

Helpful Links

• Click here and search for product information by EMA

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 26, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Androgens; Contraceptive Agents, Male; Anabolic Agents; Dienogest; Nandrolone
• Other Study ID Numbers: 13180; 2008-003611-13 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No