NCT00754871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

September 17, 2008

Last Update Submit

January 26, 2015

Conditions

Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned

    No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned

Secondary Outcomes (7)

  • Course of gonadotropins (FSH, LH, P, E2)

    During pre-treatment and treatment cycles (3 months)

  • Endometrial thickness

    During pre-treatment and treatment cycles (3 months)

  • Grading of ovarian activity

    During pre-treatment and treatment cycles (3 months)

  • Effects on the cervix and the cervical mucus

    During pre-treatment and treatment cycles (3 months)

  • mRNA expression profile of endometrial biopsies and in blood

    once in pre-treatment and during treatment

  • +2 more secondary outcomes

Study Arms (4)

Arm 1

EXPERIMENTAL
Drug: Dienogest (81150037)

Arm 2

EXPERIMENTAL
Drug: Dienogest (81150231)

Arm 3

EXPERIMENTAL
Drug: Dienogest (SH T00660A)

Arm 4

EXPERIMENTAL
Drug: Dienogest (81150746)

Interventions

Dienogest (81150037)DRUG

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

Arm 1
Dienogest (81150231)DRUG

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

Arm 2
Dienogest (SH T00660A)DRUG

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

Arm 3
Dienogest (81150746)DRUG

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

Arm 4

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 22128200RESULT

Related Links

MeSH Terms

Interventions

dienogest

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

NL(1)