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Completed

NCT Number: NCT01154192

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UCSD School of Medicine

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal CBC (Hemoglobin must be at least 11mg/dl)
  • Normal renal and liver function tests
  • Normal vital signs including normal blood pressure

Exclusion criteria

  • Pregnancy
  • On oral contraceptives
  • On insulin lowering drugs
  • On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
  • On medications that will influence androgen metabolism or clearance
  • On medications that will inhibit the cytochrome P450 enzyme system (Cimetidine, ketoconazole, etc)

Treatment and study plan

Dexamethasone

Drug

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.

Other names: recombinant human chorionic gonadotropin (r-hCG)

Recombinant human chorionic gonadotropin (r-hCG)

Drug

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.

Other names: Ovidrel

Primary outcomes

  1. 17OHP Levels After hCG

    Time frame: 24 hours

    Assess serum levels of 17OHP after stimulation with recombinant hCG

Secondary outcomes

  1. Testosterone

    Time frame: 24 hours

    Assess seruim levels of testosterone after stimulation with recombinant hCG

  2. Androstenedione

    Time frame: 24 hours

    Assess serum levels of androstenedione after stimaultion with recombinant hCG

  3. DHEA

    Time frame: 24 hours

    Assess serum levels of DHEA after stimulation with recombinant hCG

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • University of Virginia

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2010
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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