NCT05752526

A Study of Diclofenac Gel in Women With Primary Dysmenorrhea

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Daré Bioscience, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysmenorrhea Primary

Interventions

Type	Name	Description
DRUG	Diclofenac 1%	vaginal hydrogel containing 1% Diclofenac
DRUG	Diclofenac 3%	vaginal hydrogel containing 3% Diclofenac
DRUG	Placebo	vaginal hydrogel, no active ingredient

Timeline

• Start date: 2023-05-19
• Primary completion: 2023-10-10
• Completion: 2024-04-26
• First posted: 2023-03-02
• Last updated: 2025-09-04

Locations

1 site across 1 country: Australia