ClinicalTrials.gov record NCT07764328
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of Milamend on Quality of Life and Hormonal Health in Women With Self-Reported Symptoms Associated With Polycystic Ovary Syndrome (PCOS)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized, single-masked trial compares the Milamend Hormone Balance dietary supplement with a placebo in premenopausal women who report PCOS symptoms. Participants are assigned to take the study powder (1 scoop daily for 3 days, then twice daily) or matching placebo and use the Chloe app for tracking. The study collects questionnaires, menstrual cycle tracking, and at-home blood samples over about 12–13 weeks to measure quality of life, hormonal and metabolic markers, menstrual symptoms, mood, body image, and safety. Findings will inform tolerability, formulation, and the design of future studies.
What it is studying. The study compares Milamend Hormone Balance versus placebo to see if taking the supplement changes quality of life, hormonal and metabolic blood markers, menstrual cycle frequency and symptoms, general well-being, anxiety, body image, and safety/tolerability.
What the researchers hope to learn. To measure Milamend's impact on PCOS-related quality of life, menstrual cycle structure and symptoms, hormone and metabolic blood markers, general well-being, anxiety, body image, and safety/tolerability; and to provide data to guide formulation and future studies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with Polycystic Ovarian Syndrome (PCOS). Additionally, the study aims to observe the impact of the product on menstrual cycle structure and associated symptoms, on reproductive and metabolic markers, on body image concerns, anxiety and general well-being. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this product in this population. We will examine the outcomes in a broad age-range of premenopausal women who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home blood specimen collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to try the product and take part in the observational process with self-reported measures, cycle tracking and at-home blood sample collection. Findings from this study will contribute knowledge toward the tolerability and formulation of the product and the design of future studies.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Dietary supplement
- A dietary supplement powder for women
- Placebo
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Females between 18-40 years old, inclusive
- Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:
- Oligomenorrhea (<9 menstrual cycles in the past year)
- Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)
- Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year
- BMI of 18.5-35
- Owns or is willing to purchase a personal digital weight scale for monthly weight measurement.
- In good general health at the time of screening (Investigator discretion).
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
- Able to complete study assessments over the course of up to 16 weeks.
Exclusion criteria
- Any potential participants who:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Rates the impact of PCOS on their overall quality of life as "Rarely/Seldom" or "Not at all"
- Average cycle length of last 3 cycles is >50 days
- Concomitant Therapies:
- Use of hormonal contraceptives within the last 6 months.
- Use of a Co-Q10 supplement within the last 6 months.
- Use of any high dose vitamin B supplements in the last 6 months.
- Received any investigational therapies or treatments within 30 days prior to randomization.
- Use of any other alpha-inositol/myo-inositol supplement in the last 6 months.
- Pioglitazone, spironolactone or metformin in the previous 6 months.
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Perimenopausal or menopausal.
- Participants diagnosed with Diabetes Mellitus (DM) for both Type I and Type II, who are managed with Insulin, Thiazolidinediones (TZDs) or Metformin.
- Known diagnosis of other causes of oligomenorrhea (e.g. thyroid disease, primary ovarian insufficiency, hyperprolactinemia, Cushing syndrome, any disorders of sexual development or Obesity).
- Chronic hepatic, renal, or cardiovascular disease (excluding hypertension).
- Known disorders that would affect nutrient absorption (e.g., Crohn's Disease, ulcerative colitis, chronic diarrhea, Celiac Disease, Irritable Bowel Syndrome, eating disorder).
- Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- Other possible causes of oligomenorrhea such as history of disordered eating, chronic jetlag or shiftwork
- Known hypersensitivity or previous allergic reaction to the product ingredients: Vitamin B6 (as Pyridoxal-5-Phosphate), Folate (as L-5-Methyltetrahydrofolate Calcium), Zinc (as Zinc Picolinate), Selenium (as L-Selenomethionine), Chromium (as Chromium Picolinate), Myo-inositol, D-chiro-inositol, Co-enzyme Q10, Alpha Lipoic Acid, L-Glutamine, L-Carnitine Tartrate, L-Lysine (as L-Lysine HCl), L-Threonine, L-Tryptophan, beet root powder, hibiscus, or spirulina (algae) or citric acid.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Natural supplements are increasingly recognized as a viable and effective approach for impacting the multifaceted symptoms from hormone dysregulation that underlie conditions such as Polycystic Ovary Syndrome (PCOS). The investigational product for this study. Milamend Hormone Balance was developed to address multiple interlinked mechanisms common in PCOS and related endocrine concerns: insulin resistance, androgen excess, oxidative stress, thyroid dysfunction, gut dysbiosis, and mood regulation. Ingredient selection prioritized human evidence (RCTs/meta-analyses where available), bioavailable forms, and a systems approach spanning reproductive, metabolic, immune, and gut-brain axes. The product's core ingredients are designed to support hormonal balance and insulin signaling, critical for conditions like PCOS. A blend of Myo- and D-chiro-inositol in a 40:1 ratio is included as it directly mimics the body's natural physiological ratio and is the most extensively studied blend for improving insulin sensitivity and restoring menstrual regularity. This blend helps to improve ovulation and reduce symptoms of high androgens, like hirsutism and acne. Chromium picolinate further supports this by enhancing insulin receptor signaling and managing blood sugar levels and cravings. Similarly, Zinc picolinate is included due to its role in insulin metabolism, hormone balance, and antioxidant defenses, which can improve menstrual and androgen-related symptoms. The final two ingredients in this category, Coenzyme Q10 (CoQ10) and Alpha-lipoic acid (ALA), work together to support mitochondrial function and reduce oxidative stress. This is particularly beneficial for egg/embryology quality and overall cellular energy, with both ingredients showing positive results in studies related to insulin resistance and fertility outcomes. Several ingredients in the supplement provide foundational support for overall health and well-being. Folate (as 5-MTHF) is the active form of vitamin B9 and is crucial for DNA synthesis, egg maturation, and methylation pathways. It is especially beneficial for individuals with specific genetic variations (MTHFR polymorphism) that affect folate processing. Vitamin B6 (as P5P), its active form, is included to support neurotransmitter synthesis, particularly for serotonin and melatonin, which can help alleviate PMS symptoms and improve mood and sleep. Selenium, in the form of L-selenomethionine, is an essential antioxidant that supports thyroid function and the conversion of thyroid hormones. When combined with inositol, it has been shown to improve thyroid antibodies and menstrual regularity. This is especially helpful for women with both thyroid dysfunction and hormonal imbalances. The supplement also addresses common co-morbidities associated with hormonal imbalances by including a blend of amino acids. L-glutamine supports gut barrier integrity, which is often compromised in conditions like PCOS, and helps reduce inflammation. L-lysine is included for immune support and its role in collagen and elastin production, which is important for skin health. L-carnitine tartrate supports mitochondrial energy and fatty acid metabolism, helping to combat the fatigue often associated with insulin resistance. Finally, L-tryptophan is a precursor to serotonin and melatonin, helping to manage mood and sleep disturbances. L-threonine is also included to support immune function, collagen synthesis, and tissue repair, contributing to overall health and resilience.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you take part you'll be randomly assigned to receive either the Milamend Hormone Balance supplement or a placebo powder and follow the dosing (1 scoop daily for 3 days, then 1 scoop twice daily). You will complete online questionnaires and surveys (for quality of life, mood, body image, anxiety, etc.), track your menstrual cycles using an app (Chloe by People Science), and provide at-home blood samples. Study activities take place over about 12–16 weeks and the research does not create a doctor–patient relationship. You will also be asked about any side effects or tolerability during the study.
How the study is structured. This is an interventional, randomized, single-masked, parallel two-arm study. Participants are randomly assigned to the Milamend supplement powder or a matching placebo and follow the same dosing schedule (1 scoop/day for the first 3 days, then 1 scoop twice daily with food). Data are collected remotely: participant questionnaires and surveys, menstrual cycle tracking via the Chloe app, and at-home blood specimen collection at baseline and around Week 12. The study compares changes between the two groups over roughly 12–13 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Polycystic Ovarian Syndrome (PCOS). Does it apply to my diagnosis?
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Dec 23, 2025
- Primary completion
- Oct 27, 2026 (estimated)
- Study completion
- Dec 30, 2026 (estimated)
- Target enrollment
- 225 participants (estimated)
- Last updated on registry
- Aug 13, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Mila Mend Inc.
- Collaborators
- People Science, Inc.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Noah Craft, M.D., Ph.D 📞 213-328-0919 ✉ noah@peoplescience.health
- Crisel Erfe, M.D 📞 310-922-0609 ✉ crisel@peoplescience.health
Participating sites (1)
- People Science, Inc.Recruiting
Los Angeles, California, 90034 · United States
- Noah Craft, M.D., Ph.D. · 213-328-0919 · noah@peoplescience.health
Terms used on this page · explanations by MedicalUpdates.ai
- observational
- A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- randomization
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- principal investigator
- The doctor or scientist responsible for running the study at a site or overall.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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