A Study of Diclofenac Gel in Women With Primary Dysmenorrhea
Status:
Not yet recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
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.