A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the M… (NCT06939972) | Clinical Trial Compass
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 range18 Years – 35 Years
SexFEMALE
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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., …
What they're measuring
1
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)