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RECRUITING
NCT07764328
NA

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

Sponsor: Mila Mend Inc.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2025-12-23

Completion Date

2026-12-30

Last Updated

2026-08-13

Healthy Volunteers

No

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.

Locations (1)

People Science, Inc.

Los Angeles, California, United States