Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154192
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : April 23, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE June 29, 2010
First Posted Date  ICMJE June 30, 2010
Results First Submitted Date  ICMJE March 29, 2019
Results First Posted Date  ICMJE April 23, 2019
Last Update Posted Date April 30, 2019
Study Start Date  ICMJE August 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
17OHP Levels After hCG [ Time Frame: 24 hours ]
Assess serum levels of 17OHP after stimulation with recombinant hCG
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
17 hydroxyprogesterone [ Time Frame: 24 hours ]
To Assess the levels of 17 hydroxyprogesterone produced after administration of recombinant hCG.
Change History Complete list of historical versions of study NCT01154192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
  • Testosterone [ Time Frame: 24 hours ]
    Assess seruim levels of testosterone after stimulation with recombinant hCG
  • Androstenedione [ Time Frame: 24 hours ]
    Assess serum levels of androstenedione after stimaultion with recombinant hCG
  • DHEA [ Time Frame: 24 hours ]
    Assess serum levels of DHEA after stimulation with recombinant hCG
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2010)
  • Testosterone [ Time Frame: 24 hours ]
    to assess the levels of testosterone after stimulation with recombinant hCG.
  • Androstenedione [ Time Frame: 24 hours ]
    Assess the levels of androstenedione after stimulation with hCG.
  • dehydroepiandrosterone sulfate [ Time Frame: 24 hours ]
    to asses the level of dehydroepiandrosterone sulfate after hCG stimulation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
Official Title  ICMJE Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE PCOS
Intervention  ICMJE
  • 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.
    Other Name: recombinant human chorionic gonadotropin (r-hCG)
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2010)
75
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01154192
Other Study ID Numbers  ICMJE 081696
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Chang, MD, University of California, San Diego
Study Sponsor  ICMJE University of California, San Diego
Collaborators  ICMJE University of Virginia
Investigators  ICMJE
Principal Investigator: R. Jeffery Chang, M.D. UCSD School of Medicine
PRS Account University of California, San Diego
Verification Date April 2019

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