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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Women's Health; Menstrual Cramps
• Intervention / Treatment: Dietary supplement: My Happy Flo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: My Happy Flo Supplement; Participants will take two capsules of My Happy Flo daily, preferably in the morning with 8-10 oz of water and a meal, for three menstrual cycles.

Dietary supplement: My Happy Flo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Period Symptoms	Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires.	Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Vitamin D Level	Assessment of Vitamin D level through blood tests.	Baseline and Cycle 3 - each Cycle is 28 days
Changes in Iron Level	Assessment of Iron level through blood tests.	Baseline and Cycle 3 - each Cycle is 28 days

Collaborators and Investigators

• Sponsor: My Happy Flo
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Menstrual Health; Period Symptoms
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Fatigue; Dysmenorrhea
• Other Study ID Numbers: 20436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No