Surrogate End-Points or Primary Outcomes in Clinical Trials in Women with Polycystic Ovary Syndrome?

    June 2004 in “ Human Reproduction ”
    Richard S. Legro, Evan R. Myers
    Image of study
    TLDR The document suggests that clinical trials for PCOS should focus on meaningful primary outcomes like live birth rates, rather than less reliable surrogate markers.
    The document from 2004 critiques the use of surrogate end-points in clinical trials for women with Polycystic Ovary Syndrome (PCOS), emphasizing the need for primary clinical outcomes that are meaningful to patients. It points out that surrogate markers like ovulation do not guarantee pregnancy due to other factors and that there is a lack of well-validated measures for hirsutism and cardiovascular disease risk in PCOS. The paper suggests that future research should focus on primary clinical endpoints, such as hirsutism and live birth rates, and that more studies are needed to validate surrogate markers. It also notes the evolution of PCOS from a disease to a syndrome and the consensus towards using unexplained hyperandrogenemic chronic anovulation as the central diagnostic criteria, with polycystic ovary morphology as a potential additional criterion.
    Discuss this study in the Community →

    Research cited in this study

    4 / 4 results

    Related Community Posts Join

    6 / 12 results

      community How does hair loss and recovery work?

      in Chat  12 upvotes 3 months ago
      Hair loss varies due to genetic sensitivity to DHT and other factors. Treatments discussed include finasteride, minoxidil, RU58841, and microneedling.

      community Female, 30, PCOS diagnosis, MPB Norwood 2. Endo refuses to give anything other than Spironolactone. Feel like I’m at my wit’s end here.

      in Female  53 upvotes 1 year ago
      A 30-year-old female with PCOS and male pattern baldness is frustrated with her endocrinologist's recommendation of only Spironolactone and minoxidil, feeling that dutasteride, finasteride, and progesterone would be more effective. Other users suggest various online sources for treatments, warn against self-medicating due to potential risks, and recommend seeking a specialized endocrinologist or considering additional treatments like Inositol, Berberine, and dermaneedling.

      community C’est terrible - at my wits end

      in Female  449 upvotes 1 year ago
      A 29-year-old woman is experiencing gradual hair thinning since age 15, suspects Androgenic Alopecia, and has tried 5% minoxidil with little success. She has purchased various hair loss treatments including minoxidil, dutasteride, finasteride, and spironolactone, but is cautious about starting them due to potential interactions with her ADHD medication.

      community Why balding gets worse in every generation?

      in Chat  81 upvotes 6 months ago
      Balding seems to worsen with each generation, possibly due to stress, diet, and environmental factors. The user started treatments like Minoxidil and finasteride.

    Related Research

    1 / 1 results