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Pharmacodynamic Characterization of Dienogest

NCT00754871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-01-27

No results posted yet for this study

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.

Conditions

  • Pharmacodynamics

Interventions

DRUG

Dienogest (81150037)

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

DRUG

Dienogest (81150231)

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

DRUG

Dienogest (SH T00660A)

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

DRUG

Dienogest (81150746)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754871 on ClinicalTrials.gov