MedTrace Logo

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

NCT00307801 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2014-12-30

Study results available
· View outcomes & findings →

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)

1 pill per day taken orally over 7 cycles of 28 pills per cycle

DRUG

Placebo

1 pill per day taken orally over 7 cycles of 28 pills per cycle

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
2006-02-28
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Australia
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Sweden
  • Ukraine
  • United Kingdom

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 NCT00307801 on ClinicalTrials.gov