check_circleStudy Completed

pharmacodynamics

Bayer Identifier:

13180

ClinicalTrials.gov Identifier:

NCT00754871

EudraCT Number:

2008-003611-13

EU CT Number:

Not Available
Pharmacodynamic characterization of Dienogest

Trial 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.

Key Participants Requirements

Sex

Female

Age

18 - 35 Years
  • - 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
  • - 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)

Trial summary

Enrollment Goal
102
Trial Dates
September 2008 - September 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Dinox B.V.Groningen, 9713 GZ, Netherlands

Primary Outcome

  • No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
    date_rangeTime Frame:
    No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Course of gonadotropins (FSH, LH, P, E2)
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no
  • Endometrial thickness
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no
  • Grading of ovarian activity
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no
  • Effects on the cervix and the cervical mucus
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no
  • mRNA expression profile of endometrial biopsies and in blood
    date_rangeTime Frame:
    once in pre-treatment and during treatment
    enhanced_encryption
    Safety Issue:
    no
  • Concentrations of DNG in serum
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    During pre-treatment and treatment cycles (3 months)
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here and search for websynopsis results provided by BayerClick here and search for product information by EMA