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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05752526




Registration number
NCT05752526
Ethics application status
Date submitted
21/02/2023
Date registered
2/03/2023
Date last updated
11/01/2024

Titles & IDs
Public title
A Study of Diclofenac Gel in Women With Primary Dysmenorrhea
Scientific 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
Secondary ID [1] 0 0
DARE-PDM1-001
Universal Trial Number (UTN)
Trial acronym
DARE-PDM1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysmenorrhea Primary 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Diclofenac 1%
Treatment: Drugs - Diclofenac 3%
Treatment: Drugs - Placebo

Experimental: DARE-PDM1 1% Diclofenac Vaginal Gel - 1% Diclofenac in 2.5 mL Hydrogel

Experimental: DARE-PDM1 3% Diclofenac Vaginal Gel - 3% Diclofenac in 2.5 mL Hydrogel

Placebo comparator: Placebo - 2.5 mL Hydrogel


Treatment: Drugs: Diclofenac 1%
vaginal hydrogel containing 1% Diclofenac

Treatment: Drugs: Diclofenac 3%
vaginal hydrogel containing 3% Diclofenac

Treatment: Drugs: Placebo
vaginal hydrogel, no active ingredient
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Measure the systemic Level of Diclofenac after a single dose of DARE-PDM1
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Measure the systemic Level of Diclofenac after three doses of DARE-PDM1
Timepoint [2] 0 0
3 days
Primary outcome [3] 0 0
Measure the Vaginal Fluid levels of diclofenac after three doses of DARE-PDM1
Timepoint [3] 0 0
3 days
Primary outcome [4] 0 0
Measure the Vaginal Fluid levels of diclofenac after a single dose DARE-PDM1
Timepoint [4] 0 0
7 days
Primary outcome [5] 0 0
Number of participants with abnormal vaginal exam findings.
Timepoint [5] 0 0
60 days
Primary outcome [6] 0 0
Number of participants with abnormal laboratory test results.
Timepoint [6] 0 0
60 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
PARC Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daré Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05752526
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05752526