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

R

Rael

Status

Completed

Conditions

Menstrual Cramps
Dysmenorrhea

Treatments

Dietary Supplement: Topical Analgesic with Camphor and Menthol

Study type

Interventional

Funder types

Industry

Identifiers

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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