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Drotaverine in Dysmenorrhoea Treatment

NCT00292747 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2017-08-08

No results posted yet for this study

Summary

The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

Drotaverine

DRUG

Drotaverine Placebo

DRUG

Ibuprofen

DRUG

Ibuprofen Placebo

Sponsors & Collaborators

Principal Investigators

  • László Erős, MD · Sanofi-aventis, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-25
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • Hungary

Study Locations

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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 NCT00292747 on ClinicalTrials.gov