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

NCT07764328 | Recruiting

• 1 other identifier: PS27
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks

Secondary Outcomes (7)

• Menstrual Cycle Frequency, Function and Length Impact

  12 weeks

• Menstrual Cycle Symptoms Impact

  12 weeks

• General Well-Being Impact

  13 weeks

• Impact on Anxiety

  13 weeks

• Body Image Impact

  13 weeks

Other Outcomes (1)

• Study Experience Assessment

  12 weeks

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Control Arm using the placebo

Dietary Supplement: Placebo

Study Product Arm

EXPERIMENTAL

Experimental study arm will use the Milamend Hormone Balance supplement

Dietary Supplement: A dietary supplement powder for women

Interventions

A dietary supplement powder for women DIETARY_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

Study Product Arm

Placebo DIETARY_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

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Assigned woman at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mila Mend Inc.: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90034, United States

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Polycystic Ovary Syndrome; Oligomenorrhea; Hyperandrogenism

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Noah Craft, M.D., Ph.D

CONTACT

213-328-0919; noah@peoplescience.health

Crisel Erfe, M.D

CONTACT

310-922-0609; crisel@peoplescience.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 13, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

US (1)