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A Study of Diclofenac Gel in Women With Primary Dysmenorrhea — DARE-PDM1  

Dysmenorrhea Primary Clinical Trial

Official title:
A Phase 1, Multi-site, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Pharmacokinetics, Safety and Preliminary Efficacy of Two Strengths of DARE-PDM1 (1% or 3%) Versus Placebo Among Women With Symptomatic Primary Dysmenorrhea

Clinical Trial Summary

The goal of this clinical trial is to compare 1% and 3% diclofenac gel (DARE-PDM1) to placebo in women with symptomatic primary dysmenorrhea. The main question it aims to answer are: Is DARE-PDM1 1%, 3% diclofenac gel systemically safe? What are the systemic levels of DARE-PDM1 1%, 3% diclofenac gel in plasma and vaginal fluid following 1 dose and 3 doses. Participants will be seen for routine safety evaluations and complete a daily diary recording dysmenorrhea associated pain.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05752526
Study type Interventional
Source Daré Bioscience, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 19, 2023
Completion date May 2024
View Details
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