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Completed

NCT Number: NCT06939972

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.

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Key information

Conditions

Dysmenorrhea Fatigue Headache Menstrual Cramps Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Participant Perception of Product Effectiveness

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

    Evaluation of participants' perceptions of the product's effectiveness in alleviating menstrual cramps and symptoms, as assessed by a study-specific questionnaire.

Sponsors and collaborators

Lead sponsor

Rael

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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