An interventional study of A dietary supplement powder for women and Placebo in Polycystic Ovarian Syndrome (PCOS), sponsored by Mila Mend Inc.. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Mila Mend Inc. · Not applicable, Interventional, and Supportive care
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.
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 225 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Mila Mend Inc. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any potential participants who:
Concomitant Therapies:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control Arm using the placebo
Dietary Supplement: Placebo
Experimental study arm will use the Milamend Hormone Balance supplement
Dietary Supplement: A dietary supplement powder for women
1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food.
Also known as: Hormone Balance supplement
1 scoop/day mixed with ≥8 oz water for the first 3 days at study start and then increase to 1 scoop twice daily (AM/PM) with food.
Also known as: Hormone Balance Supplement Placebo
Quality of Life Impact
To evaluate the impact of Milamend product on quality of life associated with PCOS symptoms. Change in health-related quality of life score between placebo and study product group as measured by the PCOS-QOL. Baseline will be compared as well.
Time frame: 13 weeks
Menstrual Cycle Frequency, Function and Length Impact
To evaluate the impact of Milamend on menstrual cycle frequency. Change in presence of LH surges between study product and placebo groups.
Time frame: 12 weeks
Menstrual Cycle Symptoms Impact
To evaluate the impact of Milamend on menstrual cycle symptoms. Change in the incidence, characteristics and/or severity of cycle symptoms between study product and placebo groups.
Time frame: 12 weeks
General Well-Being Impact
To evaluate the impact of Milamend product on general well-being. Change in general well-being score between placebo and study product group as measured by the Patient Health Questionnaire-9 (PHQ-9). Baseline will be compared as well.
Time frame: 13 weeks
Impact on Anxiety
To evaluate the impact of Milamend on anxiety. Change in anxiety score between placebo and study product group as measured by GAD-7. Baseline will be compared as well.
Time frame: 13 weeks
Body Image Impact
To evaluate the impact of Milamend product on body image concern. Change in body image concern score between placebo and study product group as measured by the Body Image Concern Inventory (BICDI). Baseline will be compared as well.
Time frame: 13 weeks
Hormone and Metabolic Blood Marker Impact
To assess the impact of Milamend product on hormone and metabolic blood markers. Change from baseline in hormone and metabolic blood markers at Week 12 as measured by blood collection.
Time frame: Baseline to Week 12
Safety and Tolerability Assessment
To observe the safety and tolerability of Milamend's product. Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product and placebo use period.
Time frame: 12 weeks
Study Experience Assessment
To identify improvements for future participant-centered study designs using feedback Assessment of patient satisfaction survey of study experience including design and use of app-based data collection tools
Time frame: 12 weeks
Plan to share: Undecided
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