Pharmacodynamic Characterization of Dienogest

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00754871
First received: September 17, 2008
Last updated: April 14, 2013
Last verified: April 2013
  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 1

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

Resource links provided by NLM:


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 ]

Enrollment: 102
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754871

Locations
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00754871     History of Changes
Other Study ID Numbers: 13180, 2008-003611-13
Study First Received: September 17, 2008
Last Updated: April 14, 2013
Health Authority: Netherlands: Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Dienogest
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on April 15, 2014