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

NCT06939972 | Completed

• 1 other identifier: 20674
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Headaches; Mood changes; Fatigue

Outcome Measures

Primary Outcomes (1)

• Reduction in Menstrual Cramps and Pain

  Change in participant-reported menstrual cramps and associated pain severity, as assessed by a study-specific questionnaire.

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

Secondary Outcomes (1)

• 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)

Study Arms (1)

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.

Dietary Supplement: Topical Analgesic with Camphor and Menthol

Interventions

Topical Analgesic with Camphor and Menthol 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.

Topical Product Application

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rael: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Dysmenorrhea; Headache; Fatigue

Interventions

Analgesics; Camphor; Menthol

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Camphanes; Bicyclic Monoterpenes; Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Norbornanes; Monoterpenes; Terpenes; Ketones; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: April 23, 2025
• Study Start: October 3, 2024
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)