[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100127574":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":29,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":42,"whyStopped":29,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Micronized progesterone suspension","EXPERIMENTAL","Micronized progesterone 0.8 mg\u002Fkg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.",[13],"Drug: Micronized progesterone suspension",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],[25],"Progesterone",{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Placebo contains only inert ingredients and is not expected to exert any direct physiological effects",[15],null,[31],{"name":32,"affiliation":5,"role":33},"Christine M Burt Solorzano, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Melissa Gilrain","CONTACT","434-243-6911","pcos@virginia.edu",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Charlottesville","Virginia","22908","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-78.47668,38.02931,{"lat":52,"lon":51},[55,56],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},{"name":57,"role":33,"phone":29,"phoneExt":29,"email":29},"Christopher McCartney, MD",{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Christine Burt Solorzano","Professor of Pediatrics",[62],{"name":63,"class":64},"National Institutes of Health (NIH)","NIH","100127574","early-phase-1-acute-progesterone-suppression-of-wake-vs-sleep-luteinizing-hormone-pulse-frequency-in-pubertal-girls-with-and-without-hyperandrogenism-100127574",false,"NCT00929006","Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism","Study to Assess Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism","CRM003","Inclusion Criteria:\n\n* Mid- to late pubertal adolescent girl (at least Tanner breast stage 3, but no more than 2 years postmenarcheal)\n* For girls without hyperandrogenism: serum (calculated) free testosterone concentration within the Tanner stage-specific reference range and the absence of hirsutism\n* For girls with hyperandrogenism: serum (calculated) free testosterone concentration greater than the Tanner stage-specific reference range and\u002For unequivocal evidence for hirsutism\n* General good health (excepting overweight, obesity, hyperandrogenism, and adequately-treated hypothyroidism)\n* Capable of and willing to provide informed assent (adolescents under age 16 years) and\u002For consent (adolescents over age 16 years; custodial parents or guardians of all adolescent volunteers)\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* 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 elevation \\> 1.5 times the upper reference range limit. Mild elevations may be seen in adolescent HA and in PCOS, and will be accepted in these groups.\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: Mild prolactin elevations may be seen in HA\u002FPCOS, 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* 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\u002FHA\u002FPCOS; therefore, elevations \\\u003C 1.5 times the upper limit of normal will be accepted in such girls.\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 micronized progesterone.\n* Body mass index (BMI)-for-age percentile \\\u003C 5% (underweight)\n* Due to the amount of blood being drawn, adolescent volunteers with body weight \\\u003C 25 kg will be excluded.\n* Restrictions on use of other drugs or treatments: No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 2 months prior to the screening visit and in the 3 months prior to the start of the study medications. Such medications include oral contraceptive pills, progestins, metformin, systemic glucocorticoids, some antipsychotic medications, and sympathomimetics\u002Fstimulants (e.g., methylphenidate).",true,"FEMALE","10 Years","17 Years",{"count":78,"type":79},36,"ESTIMATED","INTERVENTIONAL",[82],"EARLY_PHASE1","The purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.",[85,86],"Puberty","Hyperandrogenism",[88,89,90],"hyperandrogenemia","pubertal","polycystic ovary syndrome","2025-07-30",{"date":93,"type":94},"2025-08-05","ACTUAL",{"date":96,"type":94},"2008-06",{"date":98,"type":79},"2025-12-01",{"name":5,"class":6},1]