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

NCT07764328 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-08-13

No results posted yet for this study

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)

Interventions

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • People Science, Inc.

    collaborator INDUSTRY

  • Mila Mend Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2026-10-27
Completion
2026-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07764328 on ClinicalTrials.gov