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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154192
• Other study ID #: 081696
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSD School of Medicine	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17OHP Levels After hCG	Assess serum levels of 17OHP after stimulation with recombinant hCG	24 hours
Secondary	Testosterone	Assess seruim levels of testosterone after stimulation with recombinant hCG	24 hours
Secondary	Androstenedione	Assess serum levels of androstenedione after stimaultion with recombinant hCG	24 hours
Secondary	DHEA	Assess serum levels of DHEA after stimulation with recombinant hCG	24 hours