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

NCT ID: NCT06939972

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2024-12-25

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.

Conditions

Dysmenorrhea; Menstrual Cramps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical Product Application

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.

Group Type: EXPERIMENTAL

Topical Analgesic with Camphor and Menthol

Intervention Type: DIETARY_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.

Interventions

Topical Analgesic with Camphor and Menthol

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Rael

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

20674

Identifier Type: -

Identifier Source: org_study_id