Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Oligomenorrhea

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Anti-Inflammatory Agents

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Reproductive Control Agents

Androgens

Dexamethasone

Hormones

Dexamethasone acetate

Testosterone

Chorionic Gonadotropin

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Intervention: Each subject in the Oligomenorrhea group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

recombinant human chorionic gonadotropin (r-hCG)

R. Jeffery Chang, M.D.

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU.We propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.

Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)

Assess serum levels of 17OHP after stimulation with recombinant hCG

Assess seruim levels of testosterone after stimulation with recombinant hCG

Assess serum levels of androstenedione after stimaultion with recombinant hCG

Assess serum levels of DHEA after stimulation with recombinant hCG

University of Virginia

University of California, San Diego

Principal Investigator

The number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events should be 24

PCOS Group

Normal Group

Oligomenorrhea Group

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Oligpomenorrhea subjects not part of study

Dr. R. Jeffrey Chang

17OHP Levels After hCG

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

.

Oligpmenrreha group not included in study

Oligomenorreha group not inlcuded in study

Androstenedione

Oligomenrrhea group not included in study

DHEA

Intervention: Each subject in the PCOS group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Dexamethasone: Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.

recombinant human chorionic gonadotropin (r-hCG): Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection

Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.

Dexamethasone

There Were Only 2 Groups: PCOS and Normal Subjects

Overall Study

Anovulation

Hypoglycemic Agents

Metformin

Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).

Placebo

A combined intervention of diet and exercise was employed with the goal of achieving an average weight loss of at least 7% of initial body weight over six months with a prescription of 150 min/week of exercise combined with a low-calorie diet.

Lifestyle Intervention

Richard Legro, M.D.

The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. The primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. Secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.

Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome

Count of ovulations per subject during the treatment period.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Milton S. Hershey Medical Center

Professor, Obstetrics and Gynecology and Public Health Sciences

Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion

Placebo (2 tablets twice a day) initiated in a step-up fashion

Age, Categorical

United States

Region of Enrollment

Sandy Eyer

Change in Testosterone After 6 Months of Treatment

This statistical analysis models the probability of ovulation.

This statistical analysis models the count of ovulations provided a woman actually ovulated.

A total of 76 patients with daily urine collections.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)	NCT01154192	PCOS	Dexamethasone recombinant hum...	12 Years - 18 Years	University of California, San Diego
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)	NCT00151411	Polycystic Ovar...	Metformin Placebo Lifestyle Inter...	12 Years - 39 Years	Milton S. Hershey Medical Center
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)	NCT00151411	Polycystic Ovar...	Metformin Placebo Lifestyle Inter...	12 Years - 39 Years	Milton S. Hershey Medical Center

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