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.
Females between 18-40 years old, inclusive
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
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
Use of hormonal contraceptives within the last 6 months.
Parallel
A dietary supplement powder for women
Dietary supplement1 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 supplement1 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.
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.
Menstrual Cycle Frequency, Function and Length Impact
To evaluate the impact of Milamend on menstrual cycle frequency. Change in presence of LH surges between study product and placebo groups.
Menstrual Cycle Symptoms Impact
To evaluate the impact of Milamend on menstrual cycle symptoms. Change in the incidence, characteristics and/or severity of cycle symptoms between study product and placebo groups.
General Well-Being Impact
To evaluate the impact of Milamend product on general well-being. Change in general well-being score between placebo and study product group as measured by the Patient Health Questionnaire-9 (PHQ-9). Baseline will be compared as well.
Impact on Anxiety
To evaluate the impact of Milamend on anxiety. Change in anxiety score between placebo and study product group as measured by GAD-7. Baseline will be compared as well.
Study Experience Assessment
To identify improvements for future participant-centered study designs using feedback Assessment of patient satisfaction survey of study experience including design and use of app-based data collection tools
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Mila Mend Inc.
Lead sponsor
People Science, Inc.
Collaborator
