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OpenTrials
Completed

NCT Number: NCT00754871

Pharmacodynamic Characterization of Dienogest

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.

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Key information

Conditions

Pharmacodynamics

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dienogest (81150037)

Drug

daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days

Dienogest (81150231)

Drug

daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days

Dienogest (SH T00660A)

Drug

daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days

Dienogest (81150746)

Drug

daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2008
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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