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Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea

NCT01892904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2015-09-09

No results posted yet for this study

Summary

The is a multi-center, randomized, open-label, active-controlled, parallel-group comparative study (24-week treatment period).

The objective of this study is to prove the superiority of BAY 86-5300 with flexible extended regimen for treatment of dysmenorrhea to BAY 86-5300 with 28-day cyclic regimen in terms of primary efficacy variable, number of days with dysmenorrheic pain over 140 days of evaluation period.

In addition, the long-term safety of the flexible extended regimen of BAY86-5300 in patients treated for one year will be investigated.

Conditions

  • Dysmenorrhea

Interventions

DRUG

EE20/DRSP(BAY86-5300)

One tablet \[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\] / day

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-01-31
Completion
2015-08-31

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 NCT01892904 on ClinicalTrials.gov