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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, San Diego
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01154192
First received: June 29, 2010
Last updated: January 14, 2013
Last verified: January 2013

June 29, 2010
January 14, 2013
August 2011
July 2014   (final data collection date for primary outcome measure)
17OHP [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Assess serum levels of 17OHP after stimulation with recombinant hCG
17 hydroxyprogesterone [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
To Assess the levels of 17 hydroxyprogesterone produced after administration of recombinant hCG.
Complete list of historical versions of study NCT01154192 on ClinicalTrials.gov Archive Site
  • Testosterone [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Assess seruim levels of testosterone after stimulation with recombinant hCG
  • Androstenedione [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Assess serum levels of androstenedione after stimaultion with recombinant hCG
  • DHEA [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Assess serum levels of DHEA after stimulation with recombinant hCG
  • Testosterone [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    to assess the levels of testosterone after stimulation with recombinant hCG.
  • androstenedione [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    Assess the levels of androstenedione after stimulation with hCG.
  • dehydroepiandrosterone sulfate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    to asses the level of dehydroepiandrosterone sulfate after hCG stimulation.
Not Provided
Not Provided
 
Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
PCOS
  • Drug: 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.
  • Drug: 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 of r-hCG for measurement of steroid hormones.
    Other Name: Ovidrel
  • Experimental: PCOS group
    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.
    Interventions:
    • Drug: Dexamethasone
    • Drug: recombinant human chorionic gonadotropin (r-hCG)
  • Experimental: Normal group
    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.
    Interventions:
    • Drug: Dexamethasone
    • Drug: recombinant human chorionic gonadotropin (r-hCG)
  • Experimental: Oligomenorrhea group
    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.
    Interventions:
    • Drug: Dexamethasone
    • Drug: recombinant human chorionic gonadotropin (r-hCG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
July 2014
July 2014   (final data collection date for primary outcome measure)

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)
Female
12 Years to 18 Years
Yes
Contact: R. Jeffrey Chang, M.D. 858-534-8930 rjchang@ucsd.edu
United States
 
NCT01154192
081696
Yes
Jeffrey Chang, MD, University of California, San Diego
University of California, San Diego
University of Virginia
Principal Investigator: R. Jeffery Chang, M.D. UCSD School of Medicine
University of California, San Diego
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP