DysmenorrheaNCT06939972
A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
A study testing Topical Analgesic with Camphor and Menthol in people with Dysmenorrhea and Menstrual Cramps, run by Rael at 1 site in United States.
Trial summary
This study evaluates the effectiveness of a topical product in reducing discomfort associated with menstrual cramps and back pain. Participants will apply the product during two menstrual cycles and complete study-specific questionnaires to assess the impact on symptoms and user perceptions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Menstrual Cramps
- What is being tested?
- Topical Analgesic with Camphor and Menthol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 25 Dec 2024
- Phase
- Interventional
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, aged 18-35.
- Has had a regular menstrual cycle for the past six months and is to predict their menstrual cycle and the timing of their menstruation.
- Mild to moderate self-reported discomfort during menstruation related to pelvic cramps and back pain.
- Generally healthy and not living with any uncontrolled chronic disease.
- Has a menstrual cycle between 21 and 35 days in length.
- Willing to maintain current diet, sleep, and activity level for the duration of the study.
- Resides in the United States.
Who cannot join
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Current use of any blood thinning medication.
- Anyone with known severe allergic reactions.
- Anyone with any allergies requiring the use of an Epi-Pen.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
- Anyone who is pregnant, breastfeeding, or trying to conceive currently or at any point until the end of the study period.
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- Anyone unwilling to follow the study protocol.
- Anyone taking prescription medications for acute or chronic pain.
- Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system-e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
- Anyone diagnosed with other conditions that may cause lower back, abdominal, or pelvic discomfort- e.g., fibromyalgia, Crohn's, IBS, UC, chronic constipation, frequent UTIs, bacterial vaginosis (BV), or history or kidney stones.
- Anyone who has changed their birth control in the past three months.
- Anyone who has had any surgeries or invasive treatments in the past six months or has any planned up until the end of the study period.
- Anyone with any major illness in the past three months.
- Anyone currently experiencing symptoms associated with perimenopause.
- Anyone taking part in any other clinical trials or studies during this study's duration.
- Anyone with a history of substance abuse.
- Anyone who is currently a smoker or has been in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effectiveness of a topical product in reducing discomfort associated with menstrual cramps and back pain. Participants will apply the product during two menstrual cycles and complete study-specific questionnaires to assess the impact on symptoms and user perceptions.
- Conditions
- Dysmenorrhea, Menstrual Cramps
- Being tested
- Topical Analgesic with Camphor and Menthol
- Keywords
- Headaches, Mood changes, Fatigue
- Medical subject headings
- Dysmenorrhea, Headache, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Analgesic with Camphor and MentholDietary supplement
Participants will apply the product directly to the lower abdomen or back during menstrual cycles, following specific application instructions. The product provides analgesic and cooling effects to reduce discomfort.
| Study group | Role | What they receive |
|---|---|---|
| Topical Product Application | Experimental | Participants will apply a topical product containing Camphor (4%) and Menthol (4%) to areas experiencing pain, such as the lower abdomen or lower back, during menstrual cycles. Receives: Dietary Supplement: Topical Analgesic with Camphor and Menthol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Menstrual Cramps and Pain
Change in participant-reported menstrual cramps and associated pain severity, as assessed by a study-specific questionnaire.
Measured: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
Secondary outcomes (1)
Participant Perception of Product Effectiveness
Evaluation of participants' perceptions of the product's effectiveness in alleviating menstrual cramps and symptoms, as assessed by a study-specific questionnaire.
Measured: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start3 Oct 2024
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rael
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939972
- Sponsor's protocol ID
- 20674
- Status last verified
- Apr 2025
- First submitted
- 5 Jan 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT06939972
- Acronym / sponsor ID
- 20674
- Conditions
- Dysmenorrhea, Menstrual Cramps
- Keywords
- Headaches, Mood changes, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- RaelIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 23 Apr 2025 (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.
This study evaluates the effectiveness of a topical product in reducing discomfort associated with menstrual cramps and back pain. Participants will apply the product during two menstrual cycles and complete study-specific questionnaires to assess the impact on symptoms and user perceptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Product Application | Experimental | Dietary Supplement: Topical Analgesic with Camphor and MentholParticipants will apply a topical product containing Camphor (4%) and Menthol (4%) to areas experiencing pain, such as the lower abdomen or lower back, during menstrual cycles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, aged 18-35.
- Has had a regular menstrual cycle for the past six months and is to predict their menstrual cycle and the timing of their menstruation.
- Mild to moderate self-reported discomfort during menstruation related to pelvic cramps and back pain.
- Generally healthy and not living with any uncontrolled chronic disease.
- Has a menstrual cycle between 21 and 35 days in length.
Key exclusion criteria (17 listed)
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Current use of any blood thinning medication.
- Anyone with known severe allergic reactions.
- Anyone with any allergies requiring the use of an Epi-Pen.
- Anyone with any allergies or sensitivities to any of the study product ingredients.
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 |
|---|---|---|
| Topical Analgesic with Camphor and MentholParticipants will apply the product directly to the lower abdomen or back during menstrual cycles, following specific application instructions. The product provides analgesic and cooling effects to reduce discomfort. | Dietary supplement | Topical Product Application |
Primary outcome
Reduction in Menstrual Cramps and Pain
Time frame: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
Change in participant-reported menstrual cramps and associated pain severity, as assessed by a study-specific questionnaire.
1 secondary outcome
Participant Perception of Product Effectiveness
Time frame: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
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 23 Apr 2025.
- Individual participant dataSharing planned: No
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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 study testing Topical Analgesic with Camphor and Menthol in people with Dysmenorrhea and Menstrual Cramps, run by Rael at 1 site in United States.
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 7 inclusion and 17 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 23 Apr 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Reduction in Menstrual Cramps and Pain (time frame: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)). 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 23 Apr 2025.