Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacodynamic Characterization of Dienogest

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.
 
ClinicalTrials.gov Identifier: NCT00754871
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Pharmacodynamics Drug: Dienogest (81150037) Drug: Dienogest (81150231) Drug: Dienogest (SH T00660A) Drug: Dienogest (81150746) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest

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




Primary Outcome Measures :
  1. 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 :
  1. Course of gonadotropins (FSH, LH, P, E2) [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  2. Endometrial thickness [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  3. Grading of ovarian activity [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  4. Effects on the cervix and the cervical mucus [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  5. mRNA expression profile of endometrial biopsies and in blood [ Time Frame: once in pre-treatment and during treatment ]
  6. Concentrations of DNG in serum [ Time Frame: During pre-treatment and treatment cycles (3 months) ]
  7. Safety and tolerability [ Time Frame: During pre-treatment and treatment cycles (3 months) ]


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.


Layout table for eligibility information
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)

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
Layout table for location information
Netherlands
Groningen, Netherlands, 9713 GZ
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00754871    
Other Study ID Numbers: 13180
2008-003611-13 ( EudraCT Number )
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for 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