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A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

NCT03448536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2019-10-28

Study results available
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Summary

The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.

Conditions

  • Dysmenorrhea

Interventions

DRUG

Naproxen Sodium, (Aleve, BAY117031)

220 mg \*2 tablets, orally, single dose

DRUG

Acetaminophen (Tylenol Extra Strength)

500 mg \*2 caplets, orally, single dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2018-09-05
Completion
2018-09-05
FDA Drug
Yes

Countries

  • United States

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 NCT03448536 on ClinicalTrials.gov