CompletedNot Applicable

A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle

United States40 participantsStarted 2024-10-03

Plain-language 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.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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., …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Menstrual Cramps and Pain

Timeframe: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)

Trial details

NCT IDNCT06939972

SponsorRael

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-25

View on ClinicalTrials.gov More Dysmenorrhea trials