Trials / Completed
CompletedNCT03448536
A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 201 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- 15 Years – 35 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naproxen Sodium, (Aleve, BAY117031) | 220 mg \*2 tablets, orally, single dose |
| DRUG | Acetaminophen (Tylenol Extra Strength) | 500 mg \*2 caplets, orally, single dose |
Timeline
- Start date
- 2018-04-05
- Primary completion
- 2018-09-05
- Completion
- 2018-09-05
- First posted
- 2018-02-28
- Last updated
- 2019-10-28
- Results posted
- 2019-10-28
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03448536. Inclusion in this directory is not an endorsement.