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To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea

NCT02617537 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-02-17

No results posted yet for this study

Summary

The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate \[β-CDC\]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study

Conditions

  • Dysmenorrhea

Interventions

DRUG

EE20/DRSP(YAZ,BAY86-5300)

0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle

DRUG

Placebo

Matching placebo tablets for 28 days per 28-day intake cycle

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-09-30
Completion
2017-10-31

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Entities

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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 NCT02617537 on ClinicalTrials.gov