A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.

Completed · Not applicable

Conditions studied: Menstrual Cramps, Women's Health, Fatigue

In brief

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.

Key facts

Study ID

NCT06522672

Run by

My Happy Flo

People needed

40

Starts

2024-05-31

Expected to finish

2024-08-31

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Citruslabs — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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