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

Conditions

• Polycystic Ovarian Syndrome (PCOS)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Aug 13, 2026

Start date

Dec 23, 2025

Status verified

Aug 2026

Primary completion

Oct 27, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Placebo Comparator: Placebo Arm
  Control Arm using the placebo
• Experimental: Study Product Arm
  Experimental study arm will use the Milamend Hormone Balance supplement

Primary Outcome Measure

Quality of Life Impact [ Time Frame: 13 weeks ]

Central Contacts

• Noah Craft, M.D., Ph.D
  213-328-0919
  [email protected]
• Crisel Erfe, M.D
  310-922-0609
  [email protected]

Locations (1)

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