Studies for Adolescents

Polycystic Ovary Syndrome: Studies for Adolescents

Study #1:
URINARY DENND1A.V2 AS A PREDICTOR OF PUBERTAL HYPERANDROGENEMIA

(IRB-HSR# 17633)
  • The goal of this study is to determine whether a urine test (“urine DENND1A RNA”) is associated with testosterone levels in adolescent girls.
  • We are recruiting all girls ages 8-17 years of age
  • This study requires 1 brief outpatient visit
  • No study medications
  • Compensation is a $75 gift card.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #2:
HYPERANDROGENEMIA AND ALTERED DAY-NIGHT PULSE PATTERNS 
(IRB-HSR# 18489)

Center for Research in Reproduction is seeking young female volunteers that have been diagnosed with hyperandrogenism, PCOS, or hirsutism (fascial hair) ages 10 to 17. Participants must have not taken contraceptive pills or hormonal medications for 3 months prior to the study. The goal is to learn how suppression of progesterone changes luteinizing hormone (LH) pulse frequency. Participation in this study will require 7 study visits over 2-4 months. The 1st (screening) visit would last about 1.5 hours – to make sure your daughter qualifies for the study and that it is safe for her to participate. Four outpatient visit that will last about 30 minutes each and two overnight admissions at the Clinical Research Unit that will last about 17 hours (2:00PM to 7:00AM). We will monitor hormone levels during this admission. Volunteers will take spironolactone or a placebo twice daily for a minimum of 2 weeks and up to 40 days prior to an overnight admission and three doses of progesterone on the day of the overnight admission. Compensation for completion is $500.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #3:
ASSESSMENT OF DAY-NIGHT SECRETION OF PROGESTERONE AND LH ACROSS PUBERTAL MATURATION IN GIRLS WITH AND WITHOUT HYPERANDROGENEMIA  (IRB-HSR# 13502)

Center for Research in Reproduction is seeking young healthy female volunteers ages 7 to 17 that not have taken contraceptive pills or hormonal medications for 3 months prior to the study. In this study, we aim to discover whether LH pulses are different in girls with high testosterone levels (compared to those with normal testosterone levels). This study requires 2-3 visits (1-2 outpatient visits and 1 overnight admission) to the UVA Clinical Research Unit. The 1st (screening) visit would last about 1.5 hours – to make sure your daughter qualifies for the study and that it is safe for her to participate. The overnight admission to the Clinical Research Unit will last about 20 hours (~4pm – 12pm).  This visit can occur any time following screening, but will be timed to the menstrual cycle (if appropriate). We will monitor hormone levels during this admission. There are no study medications given during this study. Compensation for completion is $300.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #4:
OVARIAN CONTROL OF LH PULSES DURING MID TO LATE PUBERTY
(IRB-HSR# 13717)
  • The goal is to assess whether elevated levels of testosterone influences suppression of LH pulses by progesterone.
  • We are recruiting girls who are Tanner stage 3-5 (and ≤ 4 years post-menarche).
  • This study requires 3 brief outpatient visits and two 20-hour (overnight) admissions (4pm-noon).
  • Subjects will take four oral doses of placebo and four oral doses of physiologic progesterone.
  • Sleep is formally monitored during admissions.
  • Compensation is a $500 gift card.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #5:
ADRENAL and OVARIAN CONTRIBUTION TO HYPERANDROGENEMIA IN NORMAL AND OBESE GIRLS
(IRB-HSR# 12702 and #15298)
  • The goal of this study is to determine the role of the adrenal glands and the ovaries in hormone production during puberty.
  • We are recruiting normal and obese girls, 7 to 18 years of age.
  • This study requires 3 brief outpatient visits and one 15-hour admission (5pm-8am).
  • Subjects will take one oral dose of dexamethasone, one IV administered dose of ACTH, and one IV administered dose of rHCG.
  • Compensation is $450-550 gift card, depending on completion of overnight admission.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #6:
HYPERANDROGENEMIA IN OBESE PERIPUBERTAL GIRLS: ROLE OF INSULIN AND LH
(IRB-HSR# 13552)
  • The goal is to evaluate the role of insulin resistance and high LH in causing elevated testosterone in obese girls.
  • We are recruiting obese (BMI-for-age percentile ≥ 95), 8 to 16 years of age, ≤ 2 years postmenarcheal girls.
  • This study requires 2 brief outpatient visits and one 20-hour (overnight) admission (4pm-noon).
  • Subjects will receive human insulin and glucose infusion (i.e., “insulin clamp” procedure), and will have insulin and glucose testing after ingesting a mixed meal.
  • Compensation is a $500 gift card.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #7:
SUPPRESSION OF DAYTIME AND NIGHTTIME LH FREQUENCY BY PROGESTERONE IN EARLY PUBERTAL GIRLS WITH AND WITHOUT HYPERANDROGENEMIA (IRB-HSR# 13660)

Center for Research in Reproduction is seeking young healthy female volunteers ages 7 to 14 that not have taken any hormonal medications for 3 months prior to the study. In this study, we aim to discover how progesterone changes LH pulses in early puberty and whether this is different in girls with high testosterone levels (compared to those with normal testosterone levels). This study requires 2-3 visits (1-2 outpatient visits and 1 overnight admission) to the UVA Clinical Research Unit. The 1st (screening) visit would last about 1.5 hours – to make sure your daughter qualifies for the study and that it is safe for her to participate. The overnight admission to the Clinical Research Unit will last about 22 hours (~9am – 7am). We will monitor hormone levels during this admission. Your daughter would take a syrup (containing either progesterone or placebo) at 11:00 am, 3:00 pm, and 7:00 pm on the day of the overnight admission. Compensation for completion is $300.

Contact:  Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.


Study #8:
GO GIRLS! FITNESS SUPPORT GROUP INTERVENTION EFFECTIVENESS STUDY (IRB-HSR# 16132)
  • In this study, we want to know if participation in a fitness support group increases enjoyment of exercise, improves average amounts of daily exercise, and improves anthropometric and biochemical indices of metabolism and PCOS among girls.
  • We are recruiting girls, 7 to 21 years of age.
  • This study requires participation in the Go Girls! program as well as completion of a questionnaire at baseline, 3 months, and 6 months; optional blood work and/or anthropometrics at those three time points, as well.
  • Compensation is a $150 gift card.

Contact: Melissa Gilrain at pcos@virginia.edu or (434) 243-6911 for more information.