Status:
COMPLETED
A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
Lead Sponsor:
Rael
Collaborating Sponsors:
Citruslabs
Conditions:
Dysmenorrhea
Menstrual Cramps
Eligibility:
FEMALE
18-35 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06939972
Start Date
October 3 2024
End Date
December 25 2024
Last Update
April 23 2025
Active Locations (1)
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1
Citruslabs
Las Vegas, Nevada, United States, 89118