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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: A dietary supplement powder for women for Polycystic Ovarian Syndrome (PCOS)

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.

Official registry: https://clinicaltrials.gov/study/NCT07764328 · Mila Mend Inc. · enrollment listed as 225

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are A dietary supplement powder for women, or Placebo. The registry lists allocation as randomized. 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).

They plan to enroll about 225 people at Los Angeles. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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)

Interventions: A dietary supplement powder for women, Placebo

Primary outcome (registry wording): Quality of Life Impact

Who it is for (from inclusion criteria)

  • Ages 18 Years to 40 Years
  • Women only
  • Females between 18-40 years old, inclusive
  • Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:
  • 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
  • Owns or is willing to purchase a personal digital weight scale for monthly weight measurement
  • In good general health at the time of screening (Investigator discretion)

Public study contact (from the registry)

Noah Craft, M.D., Ph.D

213-328-0919

noah@peoplescience.health

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07764328 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07764328?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07764328?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary