Clinical trial NCT06522672: A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
Official title: A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstrual Cramps
Women's Health
Fatigue
Keywords: Menstrual Health
Period Symptoms
Lead sponsor: My Happy Flo
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical study aims to evaluate the effectiveness of My Happy Flo, a dietary supplement, in alleviating period symptoms and heavy menstrual flows. The study involves 40 participants, who will take the supplement daily for three menstrual cycles. Primary outcomes, such as the severity of heavy flows, prolonged periods, cramps, mood, energy levels, cycle regulation, and fatigue, will be measured using validated questionnaires completed after each menstrual cycle. Secondary outcomes, including Vitamin D and Iron levels, will be assessed through blood tests at the beginning and end of the study period.


Eligibility criteria: Inclusion Criteria:

* Female, aged 18 or over
* Experiencing heavy period flows
* Two or more self-reported symptoms (prolonged periods, cramps, poor mood, fatigue, irregular cycle)
* Signs of potential anemia or iron deficiency
* No known allergies to the product ingredients
* Willing to comply with study requirements and limit caffeine intake
* Generally healthy - do not live with any uncontrolled chronic disease

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* A diagnosis of sports anemia within the previous 6 months
* Anyone with known severe allergic reactions that require an Epi-Pen
* Women who are pregnant, breastfeeding, or trying to conceive
* Anyone unwilling to follow the study protocol
* Anyone who has undergone any surgeries or invasive treatments (such as immunotherapy, chemotherapy, radiation, or biological cancer) in the last 30 days or has any planned for the next 12 weeks
* Anyone with a history of substance abuse
* Anyone currently participating or planning to participate in a research study
* Anyone taking prescription anticonvulsants (anti-seizure medications)
* Anyone taking prescription anticoagulant medications (blood thinners)
* Anyone taking any hormone-modulating medications (e.g., hormonal birth control, hormone replacement therapy, testosterone, tamoxifen, thyroid medications, etc.)
* History of hysterectomy, oophorectomy, or other surgery to the reproductive organs
* History of gynecologic cancer, such as cervical, ovarian, uterine, vaginal, or vulvar cancer
* Currently experiencing menopausal or perimenopausal symptoms
* Changes or cessation of hormonal birth control in the last three months
* Active or abnormal uterine/vaginal bleeding
* Resides in RI, NY, NJ, or AZ

Primary outcomes:
measure: Improvement in Period Symptoms
timeFrame: Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days
Secondary outcomes:
measure: Changes in Vitamin D Level
timeFrame: Baseline and Cycle 3 - each Cycle is 28 days
measure: Changes in Iron Level
timeFrame: Baseline and Cycle 3 - each Cycle is 28 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: