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

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.

Eligibility

Inclusion Criteria:

1. Females between 18-40 years old, inclusive
2. Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:
3. Oligomenorrhea (\<9 menstrual cycles in the past year)
4. Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)
5. Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year
6. BMI of 18.5-35
7. Owns or is willing to purchase a personal digital weight scale for monthly weight measurement.
8. In good general health at the time of screening (Investigator discretion).
9. Able to read and understand English.
10. Able to read, understand, and provide informed consent.
11. Able to use a personal smartphone device and download Chloe by People Science.
12. Able to receive shipment of the product at an address within the United States.
13. Able to complete study assessments over the course of up to 16 weeks.

Exclusion Criteria:

Any potential participants who:

1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.
2. Rates the impact of PCOS on their overall quality of life as "Rarely/Seldom" or "Not at all"
3. Average cycle length of last 3 cycles is \>50 days
4. Concomitant Therapies:

   1. Use of hormonal contraceptives within the last 6 months.
   2. Use of a Co-Q10 supplement within the last 6 months.
   3. Use of any high dose vitamin B supplements in the last 6 months.
   4. Received any investigational therapies or treatments within 30 days prior to randomization.
   5. Use of any other alpha-inositol/myo-inositol supplement in the last 6 months.
   6. Pioglitazone, spironolactone or metformin in the previous 6 months.
5. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
6. Perimenopausal or menopausal.
7. Participants diagnosed with Diabetes Mellitus (DM) for both Type I and Type II, who are managed with Insulin, Thiazolidinediones (TZDs) or Metformin.
8. Known diagnosis of other causes of oligomenorrhea (e.g. thyroid disease, primary ovarian insufficiency, hyperprolactinemia, Cushing syndrome, any disorders of sexual development or Obesity).
9. Chronic hepatic, renal, or cardiovascular disease (excluding hypertension).
10. Known disorders that would affect nutrient absorption (e.g., Crohn's Disease, ulcerative colitis, chronic diarrhea, Celiac Disease, Irritable Bowel Syndrome, eating disorder).
11. Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
12. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
13. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
14. Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
15. Other possible causes of oligomenorrhea such as history of disordered eating, chronic jetlag or shiftwork
16. Known hypersensitivity or previous allergic reaction to the product ingredients: Vitamin B6 (as Pyridoxal-5-Phosphate), Folate (as L-5-Methyltetrahydrofolate Calcium), Zinc (as Zinc Picolinate), Selenium (as L-Selenomethionine), Chromium (as Chromium Picolinate), Myo-inositol, D-chiro-inositol, Co-enzyme Q10, Alpha Lipoic Acid, L-Glutamine, L-Carnitine Tartrate, L-Lysine (as L-Lysine HCl), L-Threonine, L-Tryptophan, beet root powder, hibiscus, or spirulina (algae) or citric acid.
17. Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.

Conditions2

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