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A Study of Diclofenac Gel in Women With Primary Dysmenorrhea

NCT05752526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-09-04

No results posted yet for this study

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

DRUG

Diclofenac 1%

vaginal hydrogel containing 1% Diclofenac

DRUG

Diclofenac 3%

vaginal hydrogel containing 3% Diclofenac

DRUG

Placebo

vaginal hydrogel, no active ingredient

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2023-10-10
Completion
2024-04-26

Countries

  • Australia

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Entities

Drugs

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 NCT05752526 on ClinicalTrials.gov