NCT06939972CompletedNot Applicable
A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
Rael1 site in 1 country40 target enrollmentStarted: October 3, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in Menstrual Cramps and Pain
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female, aged 18-
- •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., 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.
Arms & Interventions
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.
Intervention: Topical Analgesic with Camphor and Menthol (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participant Perception of Product Effectiveness(Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks))
Investigators
Study Sites (1)
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