Recruiting

Milamend Hormone Balance

Sponsor:

Mila Mend Inc.

Code:

NCT07764328

Conditions

Polycystic Ovarian Syndrome (PCOS)

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

A dietary supplement powder for women

Placebo

Study Details

Brief summary:

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.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Study ID

NCT07764328

Start date

Dec 23, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Arm

Control Arm using the placebo

experimental: Study Product Arm

Experimental study arm will use the Milamend Hormone Balance supplement

Interventions

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.

Placebo

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.

Primary outcome measure

  • Quality of Life Impact [ Time Frame: 13 weeks ]

Central Contacts and Locations

Central contacts

Locations

People Science, Inc.

Recruiting

Los Angeles, California, United States, 90034

Contacts

More Information

Sponsor

Mila Mend Inc.

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Polycystic Ovarian Syndrome
  • PCOS
  • Quality of Life
  • Hormonal Health
  • Oligomenorrhea
  • hyperandrogenism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Mila Mend Inc. on 2026-08-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.