clinical trial · NCT05752526
A Study of Diclofenac Gel in Women With Primary Dysmenorrhea
Daré Bioscience, Inc.·phase1·completed·n = 42
Dysmenorrhea PrimaryDiclofenac 1%Diclofenac 3%Placebo
brief 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.
started
May 19, 2023
primary completion
Oct 10, 2023
completion
Apr 26, 2024
last updated
Sep 4, 2025
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol