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Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

NCT00461305 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2013-01-24

Study results available
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Summary

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Conditions

  • Dysmenorrhea

Interventions

DRUG

DRSP 3 mg/EE 20 µg (13 cycles)

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

DRUG

DRSP 3 mg/EE 30 µg (6 cycles)

1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-01-31
Completion
2009-08-31

Countries

  • Japan

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 NCT00461305 on ClinicalTrials.gov