A Study of Diclofenac Gel in Women With Primary Dysmenorrhea

Dysmenorrhea Primary Clinical Trial

— DARE-PDM1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05752526
• Other study ID #: DARE-PDM1-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 19, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Daré Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: May 2024
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dysmenorrhea
• Dysmenorrhea Primary

Intervention

Drug:
• Diclofenac 1%
vaginal hydrogel containing 1% Diclofenac
• Diclofenac 3%
vaginal hydrogel containing 3% Diclofenac
• Placebo
vaginal hydrogel, no active ingredient

Locations

Country	Name	City	State
Australia	PARC Clinical Research	Adelaide	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Daré Bioscience, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants that record a decrease in dysmenorrhea associated pain	Evaluate the efficacy of DARE-PDM1 versus placebo in reducing dysmenorrhea associated pain	60 days
Other	Use of Rescue Medications	Evaluate the number of pain medication doses needed while using DARE-PDM1	60 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of participants with abnormal vaginal exam findings.	Compare genital safety of DARE-PDM1 versus placebo through vaginal exams	60 days
Primary	Number of participants with abnormal laboratory test results.	Evaluate systemic safety of DARE-PDM1 versus placebo through safety laboratory assessments	60 days