Menstrual CrampsNCT06522672
A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
A study testing My Happy Flo in people with Menstrual Cramps and Women's Health, run by My Happy Flo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cramps, Women's Health, Fatigue
- What is being tested?
- My Happy Flo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Menstrual Cramps, Women's Health, Fatigue
- Being tested
- My Happy Flo
- Keywords
- Menstrual Health, Period Symptoms
- Medical subject headings
- Dysmenorrhea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Happy FloDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| My Happy Flo Supplement | Experimental | 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. Receives: Dietary Supplement: My Happy Flo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Period Symptoms
Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires.
Measured: Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days
Secondary outcomes (2)
Changes in Vitamin D Level
Assessment of Vitamin D level through blood tests.
Measured: Baseline and Cycle 3 - each Cycle is 28 days
Changes in Iron Level
Assessment of Iron level through blood tests.
Measured: Baseline and Cycle 3 - each Cycle is 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start31 May 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CrampsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- My Happy Flo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522672
- Sponsor's protocol ID
- 20436
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
- ClinicalTrials.gov ID
- NCT06522672
- Acronym / sponsor ID
- 20436
- Conditions
- Menstrual Cramps, Women's Health, Fatigue
- Keywords
- Menstrual Health, Period Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- My Happy FloIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 31 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My Happy Flo Supplement | Experimental | Dietary Supplement: My Happy FloParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Happy FloThe 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. | Dietary supplement | My Happy Flo Supplement |
Primary outcome
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.
2 secondary outcomes
Changes in Vitamin D Level
Time frame: Baseline and Cycle 3 - each Cycle is 28 days
Changes in Iron Level
Time frame: Baseline and Cycle 3 - each Cycle is 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Happy Flo in people with Menstrual Cramps and Women's Health, run by My Happy Flo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Period Symptoms (time frame: Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.