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

Rael

Status: Completed

Conditions: Menstrual Cramps; Dysmenorrhea

Treatments: Dietary Supplement: Topical Analgesic with Camphor and Menthol

Study type: Interventional

Funder types: Industry

Identifiers

NCT06939972

20674

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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., 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Topical Product Application

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Topical Analgesic with Camphor and Menthol