Understanding Hyperandrogenism in PCOS: Young vs. Older Women
This study is looking at how different factors contribute to hyperandrogenism (high levels of male hormones) in women with Polycystic Ovary Syndrome (PCOS). Researchers want to understand if these factors are different in younger women (20-30 years old) compared to older women (40-49 years old) with PCOS. You would receive two medications, ACTH (Cosyntropin) and rhCG (Ovidrel), each given once during the study. The main goals are to measure changes in free testosterone levels after these medications, and to look at levels of luteinizing hormone (LH) and how your ovaries respond to rhCG. The study aims to enroll 144 women who have PCOS with specific symptoms like irregular periods and high male hormone levels. The current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 144 women with PCOS, divided into younger and older age groups.
- What's involved
- You would receive ACTH (Cosyntropin) once and rhCG (Ovidrel) once. Blood samples would be taken at baseline, 30 minutes and 1 hour after ACTH, 24 hours after rhCG, and frequently overnight for 12 hours to measure LH.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements are taken at specific times after medication administration, including 24 hours after rhCG, and for 12 hours overnight for LH.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03905603
Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
UNKNOWN
EARLY_PHASE1Ages 20–49InterventionalBasic scienceUniversity of VirginiaInvestigator-initiated
~144 participants
Updated 2023-11-03 on ClinicalTrials.gov
What's tested:ACTHrhCG
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in calculated free testosterone concentrations
Measured over baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (ACTH), 24 hours after recombinant human chorionic gonadotropin (rhCG).
+4 more outcomes measured
Conditions
NCT03905603
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Virginia
Charlottesville, Virginiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Chris McCartney, MD · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
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Eligibility criteria
Inclusion
Women with PCOS aged 20-30 years and 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea (average menstrual cycle length \>45 days or fewer than 9 menses/year) or irregular menstruation (substantially inconsistent menstrual cycle length). Note: For subjects aged 40-49 years, they will be allowed to participate if they have fewer than 10 menses/year (average menstrual cycle length \>35 days) as long as they have a compelling past history of oligomenorrhea or irregular menstruation.
Exclusion
Subjects must be willing and able to provide written informed consent.
Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study
Willingness and ability to comply with scheduled visits and study procedures
Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone \[FSH\] level)
Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone \<0.5 ng/mL. As an alternative, cycle day 3 FSH \> 9 IU/L (with concomitant estradiol level \>80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH \>9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3.
History of hysterectomy and/or bilateral oophorectomy
BMI ≥ 40 kg/m2
Inability to comprehend what will be done during the study or why it will be done.
Being a study of older women with PCOS, children and men will be excluded.
Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician.
Prisoners.
History of (or clinical evidence for) Cushing's syndrome or adrenal insufficiency.
History of congenital adrenal hyperplasia or 17-hydroxyprogesterone (17-OHP) \>200 ng/dL, which suggest the possibility of congenital adrenal hyperplasia. 17-OHP will be collected during follicular phase. NOTE: if a 17-OHP \>200 ng/dL and is confirmed on repeat testing, an ACTH-stimulated 17-OHP \<1000 ng/dL will be required for study participation.
Total testosterone \>150 ng/dL, which suggests the possibility of virilizing neoplasm.
DHEA-S greater than 1.5 times the upper limit of normal range (mild elevations may be seen in PCOS, so elevations \< 1.5 times the upper limit of normal will be accepted in these groups).
Virilization
Diagnosis of diabetes mellitus (DM), fasting glucose ≥ 126 mg/dL, or a hemoglobin A1c of ≥ 6.5%.
Abnormal thyroid stimulating hormone (TSH). Subjects with stable and adequately-treated hypothyroidism, reflected by normal TSH values, will not be excluded.
Moderate to severe hyperprolactinemia. Mild prolactin elevations may be seen in PCOS, and elevations \< 1.5 times the upper limit of normal will be accepted in this group.
Persistent liver abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild transaminase elevations may be seen in women with obesity, so elevations \<1.5 times the upper limit of normal will be accepted in this group.
Hemoglobin level is less than 11 g/dL.
Persistent hematocrit \<36% and hemoglobin \<12 g/dL.
Subjects who remain anemic after two sequential months of ferrous gluconate (325 mg twice daily) will be excluded from study participation.
Abnormal sodium, potassium, or bicarbonate concentrations or elevated creatinine concentration.
Significant history of pulmonary dysfunction (e.g., asthma or COPD requiring intermittent systemic corticosteroid, pulmonary hypertension, etc.).
History of known or suspected congestive heart failure.
History of known or suspected ischemic heart disease or cerebrovascular disease.
History of moderate to severe hypertriglyceridemia (triglyceride level \> 500 mg/dL). Subjects with stable and adequately treated hypertriglyceridemia reflected by normal triglyceride values will not be excluded.
History of breast, ovarian, or endometrial cancer.
The cut off threshold for estimated dominant ovarian cyst size on the day of r-hCG injection will be 18 mm. Since the ultrasound will be assessed 3-4 days prior to r-hCG administration, we will estimate the size of the dominant follicle (at the time of r-hCG administration) using the typical rate of ovarian follicle growth of 1.4 mm per day. If the dominant follicle size exceeds the cut off threshold, the subject will be asked to repeat the transvaginal ultrasound: if menses begin within 3 weeks of the prior ultrasound, the ultrasound would be repeated during the new menstrual cycle. If menses do not occur within 3 weeks of the prior ultrasound, the ultrasound will then be scheduled at the subject's earliest convenience.
Ovarian enlargement, defined by ovarian volume greater than 15 mm on transvaginal ultrasound. If the ovarian volume exceeds the cut off threshold, the participant will be given an option to repeat the transvaginal ultrasound in 2-3 months.
History of venous thromboembolism (e.g. deep venous thrombosis (DVT), pulmonary embolism (PE)).
History of blood clotting disorders (e.g., protein C, protein S, positive antiphospholipid antibodies).
First-degree relative history of blood clotting disorder, unless the same disorder has been formally excluded for the study subject. Note: any abnormal labs may be repeated to exclude a lab error.
No medications known to affect the reproductive system can be taken in the 2 months prior to screening and 3 months prior to the study. Such medications include oral contraceptive pills, metformin, progestins, glucocorticoids, anti-psychotics and/or mood stabilizers that are known to cause hormone abnormalities.
What this trial measures
- Change in calculated free testosterone concentrationsbaseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (ACTH), 24 hours after recombinant human chorionic gonadotropin (rhCG).
pg/mL
- Mean luteinizing hormone (LH) concentrationsovernight frequent blood sampling (every 10 mininutes for 12 hours)
IU/L
- Change in ovarian 17-hydroxyprogesterone to r-hCGbaseline, and 24 hours after receiving rhCG
ng/mL
- Change in adrenal 17-hydroxyprogesterone to ACTHbaseline, 30 minutes, and 60 minutes after ACTH
ng/mL
- Mean insulin level during oral glucose tolerance testduring 2 hours of oral glucose tolerance test
uIU/mL