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

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 Overview

• Status: Completed
• Conditions: Dysmenorrhea; Menstrual Cramps
• Intervention / Treatment: Dietary supplement: Topical Analgesic with Camphor and Menthol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Perception of Product Effectiveness	Evaluation of participants' perceptions of the product's effectiveness in alleviating menstrual cramps and symptoms, 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)

Collaborators and Investigators

• Sponsor: Rael
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): December 25, 2024

Study Registration Dates

• First Submitted: January 5, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Fatigue; Mood changes; Headaches
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea; Muscle Cramp; Anti-Infective Agents; Physiological Effects of Drugs; Peripheral Nervous System Agents; Dermatologic Agents; Sensory System Agents; Antipruritics; Anti-Infective Agents, Local; Analgesics; Menthol; Camphor
• Other Study ID Numbers: 20674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No