Polycystic Ovary Syndrome

Studies for Adolescents

Study #3:
ABNORMAL OVARIAN FEEDBACK IN HYPERANDROGENEMIA/OBESITY
(IRB-HSR # 8588)

• The goal of this study is to determine how testosterone modifies control of GnRH pulse secretion by ovarian steroids.
• We are recruiting girls at all Tanner Stages (breast) 1-5 who are hyperandrogenemic (testosterone >40 ng/dl and/or hirsutism)
• Study requires 3 brief outpatient visits and two 14-hour overnight admissions (5pm-7am).
• Participants will take physiologic oral doses of estrogen and progesterone for 7 days.
• Compensation = $200 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #4:
EVOLUTION OF HYPOTHALAMIC SENSITIVITY TO OVARIAN STEROID FEEDBACK IN NORMAL PUBERTY
(IRB-HSR # 14100)

• The goal of this study is to determine how the natural rise in testosterone during normal female puberty modifies control of GnRH pulse secretion by ovarian steroids.
• We are recruiting normal premenarcheal (Tanner 1-3) girls, 8-14 years old
• Study requires three outpatient visits and two 14-hour overnight admissions (5pm-7am).
• Participants will take physiologic oral doses of estrogen and progesterone for 7 days.
• Compensation = $200 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #5:
SLEEP RELATED HORMONE SECRETION THROUGH PUBERTY AND IN OBESITY
(IRB-HSR # 9868, # 13502)

• The goal of this study is to assess day-night patterns of hormone secretion (testosterone, estradiol, progesterone, LH, and FSH), during puberty in normal weight and obese girls.
• We are recruiting normal weight and obese girls, 7-18 years old.
• This study involves one brief outpatient visit and one overnight admission (15 or 20 hours).
• No study medications.
• Compensation = $75 - $100 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #6:
OVARIAN CONTROL OF LH PULSES DURING EARLY PUBERTY
(IRB-HSR # 10504)

• The goal is to determine whether progesterone acutely alters LH secretion in early pubertal girls.
• We are recruiting normal weight, premenarcheal (Tanner 1-3) girls, 9-14 years old.
• This study requires 2 brief outpatient visits and one 19-hour (overnight) admission (2pm-9am).
• Subject will take one oral dose of either placebo or physiologic progesterone.
• Compensation = $100 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #7:
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 breast stage 3, 4, or 5 (and ≤ 2 years post-menarche), 10-17 year old.
• This study requires 3 brief outpatient visits and two 20-hour (overnight) admissions (4pm-noon).
• Subjects will take four oral doses of placebo and physiologic progesterone.
• Sleep is formally monitored during admissions.
• Compensation = $250 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #8:
NEUROENDOCRINE EFFECTS OF ANDROGEN BLOCKADE IN ADOLESCENT PCOS
(IRB-HSR # 12632)

• The goal of this study is to assess if androgen blockade restores normal sensitivity of GnRH regulation by ovarian steroids.
• We are recruiting hyperandrogenic girls, 13-17 years old.
• This study requires 5 brief outpatient visits and two 14-hour (overnight) admissions (5pm-7am).
• Subjects will take flutamide for 21 days and physiologic oral doses of estrogen and progesterone for 7 days.
• Compensation = $300 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #9:
ADRENAL CONTRIBUTION TO HYPERANDROGENEMIA
(IRB-HSR # 12702)

• The goal of this study is to determine the role of the adrenal gland hormone production during puberty.
• We are recruiting normal and obese girls, ages 7 to 18 years old.
• This study requires 2 brief outpatient visits and one 15-hour admission (5pm-8am).
• Subjects will take one oral dose of dexamethasone,and one IV administered dose of ACTH.
• Compensation = $100 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information.

Study #10:
NEUROENDOCRINE EFFECTS OF METFORMIN TREATMENT IN ADOLESCENT PCOS
(IRB-HSR # 13789)

• The goal of this study is to assess if metformin induced reduction in insulin normalizes the hypothalamic effects of elevated androgens in adolescent girls.
• We are recruiting hyperandrogenemic girls, 10 to 17.
• This study requires 6 brief outpatient visits and four 16-hour (overnight) admissions (5pm-9am).
• Subjects will have 2 OGTTs, take metformin for approximately 3 months, and take physiologic oral doses of estrogen and progesterone for a total of 14 days.
• Compensation = $400 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information

Study #11:
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), 8-16 years old, ≤ 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 = $150 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information

Study #12:
SLEEP RELATED HORMONE SECRETION IN HYPERANDROGENEMIA IN EARLY PUBERTY
(IRB-HSR # 13950)

• The goal is to see if early pubertal girls with high testosterone levels exhibit normal day-night changes of LH pulses.
• We are recruiting premenarcheal girls, 8-15 years old, both normal and hyperandrogenemic.
• This study requires 2 brief outpatient visits and one 20-hour (overnight) admission (4pm-noon).
• There are no hormonal study medications.
• Sleep is formally monitored during the admission.
• Compensation = $125 Visa gift card.

Contact Anne Gabel at pcos@virginia.edu or (434) 243-6911 for more information