Dysmenorrhea PrimaryPhase 1DARE-PDM1NCT05752526
A Study of Diclofenac Gel in Women With Primary Dysmenorrhea
A Phase 1 study testing Diclofenac 1% and Diclofenac 3% in people with Dysmenorrhea Primary, run by Daré Bioscience, Inc. at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Diclofenac 1% and Diclofenac 3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 19 May 2023to 26 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Diclofenac 1%, Diclofenac 3%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac 1%Drug
vaginal hydrogel containing 1% Diclofenac
Diclofenac 3%Drug
vaginal hydrogel containing 3% Diclofenac
PlaceboDrug
vaginal hydrogel, no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| DARE-PDM1 1% Diclofenac Vaginal Gel | Experimental | 1% Diclofenac in 2.5 mL Hydrogel Receives: Drug: Diclofenac 1% |
| DARE-PDM1 3% Diclofenac Vaginal Gel | Experimental | 3% Diclofenac in 2.5 mL Hydrogel Receives: Drug: Diclofenac 3% |
| Placebo | Placebo comparator | 2.5 mL Hydrogel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days
Number of participants with abnormal vaginal exam findings.
Compare genital safety of DARE-PDM1 versus placebo through vaginal exams
Measured: 60 days
Number of participants with abnormal laboratory test results.
Evaluate systemic safety of DARE-PDM1 versus placebo through safety laboratory assessments
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start19 May 2023
- Primary completion10 Oct 2023
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752526
- Sponsor's protocol ID
- DARE-PDM1-001
- Acronym
- DARE-PDM1
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision has not yet been made on when or what IPD to share when available.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05752526
- Acronym / sponsor ID
- DARE-PDM1 / DARE-PDM1-001
- Conditions
- Dysmenorrhea Primary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Daré Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DARE-PDM1 1% Diclofenac Vaginal Gel | Experimental | Drug: Diclofenac 1%1% Diclofenac in 2.5 mL Hydrogel |
| DARE-PDM1 3% Diclofenac Vaginal Gel | Experimental | Drug: Diclofenac 3%3% Diclofenac in 2.5 mL Hydrogel |
| Placebo | Placebo comparator | Drug: Placebo2.5 mL Hydrogel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac 1%vaginal hydrogel containing 1% Diclofenac | Drug | DARE-PDM1 1% Diclofenac Vaginal Gel |
| Diclofenac 3%vaginal hydrogel containing 3% Diclofenac | Drug | DARE-PDM1 3% Diclofenac Vaginal Gel |
| Placebovaginal hydrogel, no active ingredient | Drug | Placebo |
Primary outcome
Measure the systemic Level of Diclofenac after a single dose of DARE-PDM1
Time frame: 7 days
Evaluate the plasma pharmacokinetics of diclofenac after a single dose of DARE-PDM1
Measure the systemic Level of Diclofenac after three doses of DARE-PDM1
Time frame: 3 days
Evaluate the plasma pharmacokinetics of diclofenac after three doses of DARE-PDM1
Measure the Vaginal Fluid levels of diclofenac after three doses of DARE-PDM1
Time frame: 3 days
Evaluate the vaginal fluid pharmacokinetics of diclofenac after three doses of DARE-PDM1
Measure the Vaginal Fluid levels of diclofenac after a single dose DARE-PDM1
Time frame: 7 days
Evaluate the vaginal fluid pharmacokinetics of diclofenac after a single dose of DARE-PDM1
Number of participants with abnormal vaginal exam findings.
Time frame: 60 days
Compare genital safety of DARE-PDM1 versus placebo through vaginal exams
Number of participants with abnormal laboratory test results.
Time frame: 60 days
Evaluate systemic safety of DARE-PDM1 versus placebo through safety laboratory assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No. A decision has not yet been made on when or what IPD to share when available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diclofenac 1% and Diclofenac 3% in people with Dysmenorrhea Primary, run by Daré Bioscience, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the systemic Level of Diclofenac after a single dose of DARE-PDM1 (time frame: 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.