We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacodynamic Characterization of Dienogest

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754871
First Posted: September 18, 2008
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  • Endometrial thickness [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  • Grading of ovarian activity [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  • Effects on the cervix and the cervical mucus [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  • mRNA expression profile of endometrial biopsies and in blood [ Time Frame: once in pre-treatment and during treatment ]
  • Concentrations of DNG in serum [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  • Safety and tolerability [ Time Frame: During pre-treatment and treatment cycles (3 months) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754871


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

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00754871     History of Changes
Other Study ID Numbers: 13180
2008-003611-13 ( EudraCT Number )
First Submitted: September 17, 2008
First Posted: September 18, 2008
Last Update Posted: January 27, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Dienogest
Nandrolone
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Hormones
Anabolic Agents