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Completed

NCT Number: NCT06522672

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

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.

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Key information

Conditions

Menstrual Cramps Dysmenorrhea Fatigue Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Women's Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

My Happy Flo

Dietary Supplement

The intervention aims to alleviate period symptoms including heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue. Blood tests for Vitamin D and Iron levels will be conducted at Baseline and after the third menstrual cycle. Participants will complete validated questionnaires assessing period symptoms after each menstrual cycle.

Primary outcomes

  1. Improvement in Period Symptoms

    Time frame: Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days

    Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires.

Secondary outcomes

  1. Changes in Vitamin D Level

    Time frame: Baseline and Cycle 3 - each Cycle is 28 days

    Assessment of Vitamin D level through blood tests.

  2. Changes in Iron Level

    Time frame: Baseline and Cycle 3 - each Cycle is 28 days

    Assessment of Iron level through blood tests.

Sponsors and collaborators

Lead sponsor

My Happy Flo

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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