A Study of Diclofenac Gel in Women With Primary Dysmenorrhea

NCT05752526 | Completed Phase 1

• 1 other identifier: DARE-PDM1-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea Primary

Outcome Measures

Primary Outcomes (6)

• Measure the systemic Level of Diclofenac after a single dose of DARE-PDM1

  Evaluate the plasma pharmacokinetics of diclofenac after a single dose of DARE-PDM1

  7 days

• Measure the systemic Level of Diclofenac after three doses of DARE-PDM1

  Evaluate the plasma pharmacokinetics of diclofenac after three doses of DARE-PDM1

  3 days

• Measure the Vaginal Fluid levels of diclofenac after three doses of DARE-PDM1

  Evaluate the vaginal fluid pharmacokinetics of diclofenac after three doses of DARE-PDM1

  3 days

• Measure the Vaginal Fluid levels of diclofenac after a single dose DARE-PDM1

  Evaluate the vaginal fluid pharmacokinetics of diclofenac after a single dose of DARE-PDM1

  7 days

• Number of participants with abnormal vaginal exam findings.

  Compare genital safety of DARE-PDM1 versus placebo through vaginal exams

  60 days

• Number of participants with abnormal laboratory test results.

  Evaluate systemic safety of DARE-PDM1 versus placebo through safety laboratory assessments

  60 days

Other Outcomes (2)

• Number of participants that record a decrease in dysmenorrhea associated pain

  60 days

• Use of Rescue Medications

  60 days

Study Arms (3)

DARE-PDM1 1% Diclofenac Vaginal Gel

EXPERIMENTAL

1% Diclofenac in 2.5 mL Hydrogel

Drug: Diclofenac 1%

DARE-PDM1 3% Diclofenac Vaginal Gel

EXPERIMENTAL

3% Diclofenac in 2.5 mL Hydrogel

Drug: Diclofenac 3%

Placebo

PLACEBO COMPARATOR

2.5 mL Hydrogel

Drug: Placebo

Interventions

Diclofenac 1% DRUG

vaginal hydrogel containing 1% Diclofenac

DARE-PDM1 1% Diclofenac Vaginal Gel

Diclofenac 3% DRUG

vaginal hydrogel containing 3% Diclofenac

DARE-PDM1 3% Diclofenac Vaginal Gel

Placebo DRUG

vaginal hydrogel, no active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females ages 18- 50 years old (inclusive)
• Self-assessment of historic dysmenorrhea associated pain level of ≥ 5 on a scale of 0 - 10 in at least one of the following anatomic sites: pelvic/vaginal pain, low back pain, while not using NSAIDs or hormonal contraception.
• Non-pregnant status
• If applicable, agrees to be sexually abstinent and place nothing in the vagina during the 120 hours between visits 3 and 8 and the 3-day period of the multiple dose regimen.
• Agrees to use adequate non-hormonal birth control during the trial (e.g. study provided male condoms without nonoxynol-9 lubricant, tubal sterilization, heterosexual abstinence) (Because hormonal birth control is a known off label treatment for dysmenorrhea, if the participant is on hormonal birth control other than Depo-Provera contraceptive injection, she agrees to discontinue it and have at least one spontaneous intervening menses before the start of the study period. If using Depo Provera, has not had an injection within the 4 months before Visit 1 and must have had a spontaneous menses prior to visit 2.)
• Provides informed consent for participating in the trial
• Willingness to use only study-provided oral paracetamol as rescue pain medication for dysmenorrhea, if needed according to investigator's instruction.
• Patient is fluent in the English language.
• Patient is capable of understanding and complying with the protocol and agrees to sign the informed consent document.
• Patient has had a cervical screen performed within five years prior to Visit 1 and can provide documentation indicating normal test results consistent with Australian Health guidelines. If the patient cannot provide documentation, a cervical screen will be performed at Visit 1. Patients with abnormal findings will be excluded from study participation and be referred for follow-up medical care as appropriate.

You may not qualify if:

• Positive pregnancy test
• Unwilling or unable to comply with protocol
• Allergic to diclofenac or other non-steroidal anti-inflammatory drugs (NSAIDs)
• Patients with severe liver, kidney or heart failure
• After the use of aspirin or other nonsteroidal anti-inflammatory drugs, asthma, nasal polyps, angioedema and urticaria have occurred in the past
• Current active peptic ulcer bleeding or perforation
• Have a history of significant upper gastrointestinal disease
• Have a chronic pain syndrome other than dysmenorrhea which could confound preliminary efficacy data (e.g., chronic low back pain unrelated to menses)
• Have a positive Sexually Transmitted Infection (STI) test at screening for Chlamydia trachomatis or Neisseria gonorrhea

Sponsors & Collaborators

• Daré Bioscience, Inc.: lead

Study Sites (1)

PARC Clinical Research

Adelaide, Western Australia, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: May 19, 2023
• Primary Completion: October 10, 2023
• Study Completion: April 26, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)