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Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

NCT00293059 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2013-11-27

Study results available
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Summary

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Conditions

  • Metrorrhagia

Interventions

DRUG

Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle)

DRUG

Placebo

Matching placebo to be taken orally daily.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT00293059 on ClinicalTrials.gov