Clinical trial NCT06939972: A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
Official title: A Single Group Study to Evaluate the Effects of a Topical Product on Cramps Associated With the Menstrual Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea
Menstrual Cramps
Keywords: Headaches
Mood changes
Fatigue
Lead sponsor: Rael
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2025-04-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Menstrual Cramps and Pain
timeFrame: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
Secondary outcomes:
measure: Participant Perception of Product Effectiveness
timeFrame: Baseline, Day 5 of Cycle 1 (cycle 1 is 4 weeks), and Day 5 of Cycle 2 (cycle 2 is 4 weeks)
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Citruslabs
state: Nevada
Study officials:
References: