This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.

Official record

Identifier

NCT07764328

Recruiting locations

country

United States

Interventions studied

A dietary supplement powder for womenPlacebo

Lead sponsor

Mila Mend Inc.

Target enrolment

225 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Aug 13, 2026

Last updated on the registry

Aug 13, 2026

Age

18 Years – 40 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Ovarian Cancer