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Notice of Special Interest: Optimizing Precision Treatment of Gynecologic, Reproductive and Obstetrical Outcomes in Adolescents and Adults with PCOS and Associated Comorbid Conditions (Clinical Trial Optional)
The National Institute of Child Health and Human Development (NICHD) is issuing this Notice of Special Interest (NOSI) to announce the opportunity for investigators to apply for funding to optimize treatments of comorbid conditions in adolescents and reproductive age women with a diagnosis of Polycystic Ovary Syndrome (PCOS).
The goals of this initiative are to stimulate interdisciplinary scientific collaboration between gynecologists/reproductive endocrinologists/obstetricians and subspecialists in diverse medical fields, including cardiologists, endocrinologists, gastroenterologists, psychiatrists, mental health professionals, pulmonologists, among others, to: 1) advance individualized treatments consistent with gynecologic, reproductive and obstetrical needs and desires; 2) promote translational and clinical research to increase knowledge and understanding of interaction of various therapies on gynecologic, reproductive and obstetric outcomes; and 3) discover and develop novel safe and more effective therapies for adolescents and women with PCOS with underlying comorbid conditions. Ultimately, this research would advance precision therapeutics for adolescents and adults with PCOS who have concomitant medical conditions.
This notice applies to due dates on or after February 05, 2021 and subsequent receipt dates through September 8, 2023.
Areas of Interest
Studies using new approaches and alternative treatments that address the most optimal medications for co-occurring conditions such as gestational diabetes, metabolic syndrome, depression, disordered sleep, NALFD, dyslipidemia, among others, are needed to expand options for persons with PCOS. Additional knowledge gaps exist in how various therapies affect gynecologic, reproductive, and obstetrical sequelae of PCOS. Research addressing these knowledge gaps could yield safer and more effective treatments for various presentations of PCOS, leading to paradigm changes and scientific advances in individualized and precision therapy for adolescents and adults with PCOS.
Specific areas of interest include, but are not limited to, the following examples:
- Studies to investigate effects of therapies of specific comorbid conditions on gynecologic, reproductive and/or obstetrical outcomes occurring in persons with PCOS.
- Studies of the safety and efficacy of specific treatments addressing comorbid conditions (obesity, insulin resistance, anxiety, depression, sleep disorders, sleep disordered breathing, hyperandrogenism, endometrial hyperplasia, among others) that do not preclude pregnancy or breast-feeding in persons with PCOS.
- Discovery of novel treatments of various components of metabolic syndrome in women with PCOS that have beneficial or non-deleterious impact on gynecologic, reproductive, obstetrical and perinatal outcomes.
- Studies to identify pharmacologic treatments for anxiety and/or depression in adolescents and women with PCOS, including in the postpartum period, that do not interfere with fecundability, sexual function, obstetrical outcomes, and are safe in lactating women.
- Studies investigating how treatments for PCOS affect the development of or risk for comorbid conditions, as well as studies investigating adjuvants used in conjunction with therapies to stimulate ovulation will not be considered responsive.