Clinical trial NCT00754871: Pharmacodynamic Characterization of Dienogest
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacodynamics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-18
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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)

Primary outcomes:
measure: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
timeFrame: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
Secondary outcomes:
measure: Course of gonadotropins (FSH, LH, P, E2)
timeFrame: During pre-treatment and treatment cycles (3 months)
measure: Endometrial thickness
timeFrame: During pre-treatment and treatment cycles (3 months)
measure: Grading of ovarian activity
timeFrame: During pre-treatment and treatment cycles (3 months)
measure: Effects on the cervix and the cervical mucus
timeFrame: During pre-treatment and treatment cycles (3 months)
measure: mRNA expression profile of endometrial biopsies and in blood
timeFrame: once in pre-treatment and during treatment
measure: Concentrations of DNG in serum
timeFrame: During pre-treatment and treatment cycles (3 months)
measure: Safety and tolerability
timeFrame: During pre-treatment and treatment cycles (3 months)
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270011423664. Epub 2011 Nov 29.