Pharmacodynamic Characterization of Dienogest - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00754871

Purpose

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.

Condition	Intervention	Phase
Pharmacodynamics	Drug: Dienogest (81150037) Drug: Dienogest (81150231) Drug: Dienogest (SH T00660A) Drug: Dienogest (81150746)	Phase I

Drug Information available for: Dienogest

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacodynamics Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned [ Time Frame: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]
Endometrial thickness [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]
Grading of ovarian activity [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]
Effects on the cervix and the cervical mucus [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]
mRNA expression profile of endometrial biopsies and in blood [ Time Frame: once in pre-treatment and during treatment ] [ Designated as safety issue: No ]
Concentrations of DNG in serum [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: During pre-treatment and treatment cycles (3 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Dienogest (81150037) daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days
Arm 2: Experimental	Drug: Dienogest (81150231) daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days
Arm 3: Experimental	Drug: Dienogest (SH T00660A) daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days
Arm 4: Experimental	Drug: Dienogest (81150746) daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 month 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 gynaecological examination, laboratory examination)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754871

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Netherlands
	Recruiting
Groningen, Netherlands, 9713 GZ

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Head Clinical Pharmacology )
Study ID Numbers:	13180, EudraCT: 2008-003611-13
Study First Received:	September 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00754871
Health Authority:	Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Healthy
Dienogest

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Hormone Antagonists
Therapeutic Uses
Physiological Effects of Drugs

Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009