MedTrace Logo

SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study

NCT00511797 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2017-01-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

SH T04740B

Drospirenone 1mg/EE 20µg (ß-CDC)

DRUG

SH T00186DF

Drospirenone 3 mg/EE 20µg (ß-CDC)

DRUG

SH T04740F

Drospirenone 2 mg/EE 20µg (ß-CDC)

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Japan

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 NCT00511797 on ClinicalTrials.gov