[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316551":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":34,"responsibleParty":57,"collaborators":31,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":37,"whyStopped":31,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Virginia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transdermal Estradiol","EXPERIMENTAL","Subjects will undergo estradiol administration for up to 9 days. Transdermal estradiol patches will be applied each day by study staff during study days two through nine (patches deliver 0.1 mg\u002Fday for a total dose of up to 0.6 mg\u002Fday).",[13],"Drug: Estradiol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Estradiol","Subjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg\u002Fml. Estradiol is a natural hormone.",[9],[21],"Vivelle",[23],{"name":24,"affiliation":5,"role":25},"Christine Burt Solorzano, M.D.","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Melissa G Gilrain, B.S.","CONTACT","434-243-6911",null,"pcos@virginia.edu",{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Virginia Clinical Research Unit","RECRUITING","Charlottesville","Virginia","22908","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-78.47668,38.02931,{"lat":47,"lon":46},[50,51,53,54],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":24,"role":29,"phone":30,"phoneExt":31,"email":52},"cmb6w@virginia.edu",{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"name":55,"role":56,"phone":31,"phoneExt":31,"email":31},"Christopher R McCartney, M.D.","SUB_INVESTIGATOR",{"type":25,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Christine Burt Solorzano","Dr., MD, Associate Professor of Pediatric Endocrinology","100316551","early-phase-1-study-to-assess-potential-impairments-in-estradiol-augmentation-of-gonadotropin-secretion-in-polycystic-ovary-syndrome-100316551",false,"NCT03401047","Study to Assess Potential Impairments in Estradiol Augmentation of Gonadotropin Secretion in Polycystic Ovary Syndrome","CRM009","Inclusion Criteria:\n\n* PCOS group: post-pubertal (\\> 4 years post-menarche) adult woman aged 18-30 years with PCOS, defined as clinical and\u002For laboratory evidence of hyperandrogenism (hirsutism and\u002For elevated serum \\[calculated\\] free testosterone concentration) plus ovulatory dysfunction (irregular menses, fewer than 9 per year), but without evidence for other potential causes of hyperandrogenism and\u002For ovulatory dysfunction\n* Control group: post-pubertal (\\> 4 years post-menarche) adult woman aged 18-30 years with regular menstrual periods (every 26-35 days) and no evidence of hyperandrogenism (i.e., no hirsutism, normal serum \\[calculated\\] free testosterone concentration)\n* General good health (excepting overweight, obesity, PCOS, and adequately-treated hypothyroidism)\n* Capable of and willing to provide informed consent\n* Willing to strictly avoid pregnancy with use of reliable non-hormonal methods during the study period\n\nExclusion Criteria:\n\n* Inability\u002Fincapacity to provide informed consent\n* Males will be excluded (hyperandrogenism is unique to females)\n* Age \\\u003C 18 years (we do not propose to study children because we have no preliminary data that would support this particular study in children)\n* Age \\> 30 years (since ovarian reserve may decrease beyond age 30)\n* Obesity resulting from a well-defined endocrinopathy or genetic syndrome\n* Positive pregnancy test or current lactation\n* Evidence for non-physiologic or non-PCOS causes of hyperandrogenism and\u002For anovulation\n* Evidence of virilization (e.g., rapidly progressive hirsutism, deepening of the voice, clitoromegaly)\n* Total testosterone \\> 150 ng\u002Fdl, which suggests the possibility of virilizing ovarian or adrenal tumor\n* DHEA-S greater than upper reference range limit for controls; and DHEA-S elevation \\> 1.5 times the upper reference range limit for PCOS. Mild elevations may be seen in PCOS, and will be accepted in this group.\n* Early morning 17-hydroxyprogesterone \\> 200 ng\u002Fdl measured in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia (if elevated during the luteal phase, the 17-hydroxyprogesterone will be repeated during the follicular phase). NOTE: If a 17-hydroxyprogesterone \\> 200 ng\u002Fdl is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone \\\u003C 1000 ng\u002Fdl will be required for study participation.\n* Abnormal thyroid stimulating hormone (TSH): Note that subjects with stable and adequately treated primary hypothyroidism, reflected by normal TSH values, will not be excluded.\n* Hyperprolactinemia: Any degree of hyperprolactinemia (confirmed on repeat) will be grounds for exclusion for subjects without PCOS. Hyperprolactinemia \\> 20% higher than the upper limit of normal will be grounds for exclusion for subjects without PCOS. Mild prolactin elevations may be seen in PCOS, and elevations within 20% higher than the upper limit of normal will be accepted in this group.\n* History and\u002For physical exam findings suggestive of Cushing's syndrome, adrenal insufficiency, or acromegaly\n* History and\u002For physical exam findings suggestive of hypogonadotropic hypogonadism (e.g., symptoms of estrogen deficiency) including functional hypothalamic amenorrhea (which may be suggested by a constellation of symptoms including restrictive eating patterns, excessive exercise, psychological stress, etc.)\n* Persistent hematocrit \\\u003C 36% and hemoglobin \\\u003C 12 g\u002Fdl\n* Severe thrombocytopenia (platelets \\\u003C 50,000 cells\u002Fmicroliter) or leukopenia (total white blood count \\\u003C 4,000 cells\u002Fmicroliter)\n* Previous diagnosis of diabetes, fasting glucose \\> or = 126 mg\u002Fdl, or a hemoglobin A1c \\> or = 6.5%\n* Persistent liver panel abnormalities, with two exceptions. Mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Also, mild transaminase elevations may be seen in obesity\u002FPCOS; therefore, elevations \\\u003C 1.5 times the upper limit of normal will be accepted in these groups.\n* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure, asthma requiring intermittent systemic corticosteroids, etc.)\n* Decreased renal function evidenced by GFR \\\u003C 60 ml\u002Fmin\u002F1.73m2\n* A personal history of breast, ovarian, or endometrial cancer\n* History of any other cancer diagnosis and\u002For treatment (with the exception of basal cell or squamous cell skin carcinoma) unless they have remained clinically disease free (based on appropriate surveillance) for five years\n* History of allergy to transdermal estradiol patches\n* BMI \\\u003C 18 or \\> 40 kg\u002Fm2; BMI \\\u003C 18 kg\u002Fm2 is considered to be underweight, while \\> 40 kg\u002Fm2 is considered to be class 3 obesity -- both may have marked confounding effects for the outcomes of interest\n* Menstrual cycles lasting fewer than 26 days: Cycle frequency \\\u003C 26 days suggest the possibility of relatively short follicular phases (e.g., \\\u003C 12 days). If a subject with a follicular phase shorter than 12 days participates in Aim 1c, they could experience an endogenous gonadotropin surge under surveillance. Since we wish to capture only experimentally-induced surges, we will exclude such subjects.",true,"FEMALE","18 Years","30 Years",{"count":72,"type":73},37,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","The purpose of this study is to determine if estradiol augmentation of luteinizing hormone (LH) secretion secretion (primary endpoint) and follicle-stimulating hormone (FSH) secretion (secondary endpoint) is reduced in adult women with polycystic ovary syndrome.",[79],"Polycystic Ovary Syndrome",[81],"Polycystic ovary syndrome","2025-07-30",{"date":84,"type":85},"2025-08-05","ACTUAL",{"date":87,"type":85},"2017-11-30",{"date":89,"type":73},"2025-12-01",{"name":5,"class":6},1]