Clinical trial Recruiting at 1 site Interventional Ages 18 to 40 Women only

Can Milamend Hormone Balance help with PCOS symptoms in women

Official title: 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)

Run by Mila Mend Inc. · NCT07764328 · Data updated 2026-11-12

This study will see if Milamend Hormone Balance can help improve hormonal health and quality of life for women with self-reported PCOS symptoms.

More Polycystic Ovary Syndrome (PCOS) trials

Quick facts

Study typeInterventional
Ages18 Years to 40 Years
SexWomen only
Enrollment225 (estimated)
SponsorMila Mend Inc.
Industry-sponsored
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedDecember 23, 2025
Main results expectedOctober 27, 2026
Study endsDecember 30, 2026
Registry record updatedAugust 13, 2026
Trial IDNCT07764328 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18-40 with self-reported or diagnosed PCOS, presenting oligomenorrhea or signs of hyperandrogenism, and willingness to use a smartphone app and home testing.

Probably not a fit

Individuals without PCOS features, those outside the BMI range, or those unable to complete digital assessments may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a decentralized, consumer-driven study evaluating Milamend Hormone Balance, a dietary supplement, for women with self-reported PCOS symptoms. Participants will complete questionnaires online and perform at-home blood collection to assess quality of life, menstrual regularity, reproductive and metabolic markers, and well-being over up to 16 weeks. There is no formal doctor-patient relationship in this research, as participants act as consumers making informed choices. The study uses a placebo-controlled design with a dietary supplement and expects to gather data on hormonal balance and related symptoms across a broad age range of premenopausal women. Digital tools and remote participation aim to reflect real-world use of the product.

Why it matters

Potential benefit: Participants could experience improved hormonal balance and quality of life if the product is beneficial.

How similar studies have gone: Previous research supports inositol-based blends for insulin sensitivity and menstrual regularity, but consumer-driven, decentralized approaches remain relatively novel in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Females between 18-40 years old, inclusive
2. Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:
3. Oligomenorrhea (\<9 menstrual cycles in the past year)
4. Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)
5. Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year
6. BMI of 18.5-35
7. Owns or is willing to purchase a personal digital weight scale for monthly weight measurement.
8. In good general health at the time of screening (Investigator discretion).
9. Able to read and understand English.
10. Able to read, understand, and provide informed consent.
11. Able to use a personal smartphone device and download Chloe by People Science.
12. Able to receive shipment of the product at an address within the United States.
13. Able to complete study assessments over the course of up to 16 weeks.

Exclusion Criteria:

Any potential participants who:

1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
2. Rates the impact of PCOS on their overall quality of life as "Rarely/Seldom" or "Not at all"
3. Average cycle length of last 3 cycles is \>50 days
4. Concomitant Therapies:

   1. Use of hormonal contraceptives within the last 6 months.
   2. Use of a Co-Q10 supplement within the last 6 months.
   3. Use of any high dose vitamin B supplements in the last 6 months.
   4. Received any investigational therapies or treatments within 30 days prior to randomization.
   5. Use of any other alpha-inositol/myo-inositol supplement in the last 6 months.
   6. Pioglitazone, spironolactone or metformin in the previous 6 months.
5. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
6. Perimenopausal or menopausal.
7. Participants diagnosed with Diabetes Mellitus (DM) for both Type I and Type II, who are managed with Insulin, Thiazolidinediones (TZDs) or Metformin.
8. Known diagnosis of other causes of oligomenorrhea (e.g. thyroid disease, primary ovarian insufficiency, hyperprolactinemia, Cushing syndrome, any disorders of sexual development or Obesity).
9. Chronic hepatic, renal, or cardiovascular disease (excluding hypertension).
10. Known disorders that would affect nutrient absorption (e.g., Crohn's Disease, ulcerative colitis, chronic diarrhea, Celiac Disease, Irritable Bowel Syndrome, eating disorder).
11. Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
12. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
13. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
14. 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.
15. Other possible causes of oligomenorrhea such as history of disordered eating, chronic jetlag or shiftwork
16. 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.
17. 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.

Where it's running

  • People Science, Inc.
    Los Angeles, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Evaluating biomarkers for diagnosing PCOS in young women

    This study is testing new blood markers to see if they can help doctors better diagnose Polycystic Ovarian Syndrome (PCOS) in young women aged 15-25.

    Recruiting University Hospital Erlangen · Erlangen · NCT06642831

  • Using LC-MS/MS to profile androgens for PCOS diagnosis

    This study tests whether LC-MS/MS measurement of androgen profiles can help diagnose PCOS in women compared with healthy controls.

    Recruiting Women's Hospital School Of Medicine Zhejiang University · Hangzhou, Zhejiang · NCT07916909

  • Brown adipose tissue responses in PCOS with infrared thermography and inositol

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.