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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01154192 (opens ClinicalTrials.gov in a new tab)Other id081696
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
24 participants (actual)
Sponsor
University of California, San Diego · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Aug 2011
Primary completion
Jul 2014
Completion
Sept 2014
First posted
30 Jun 2010 (estimated)
Last update posted
30 Apr 2019
Conditions
PCOS

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 3

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

    NCT01154192

    Aug 2011 to Sept 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DexamethasoneDrug
  • recombinant human chorionic gonadotropin (r-hCG)Drug

Arms3

  • 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.

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 17OHP Levels After hCG

    Time frame · 24 hours

    Registry description

    Assess serum levels of 17OHP after stimulation with recombinant hCG

Secondary outcomes(3)

  1. Testosterone

    Time frame · 24 hours

    Registry description

    Assess seruim levels of testosterone after stimulation with recombinant hCG

  2. Androstenedione

    Time frame · 24 hours

    Registry description

    Assess serum levels of androstenedione after stimaultion with recombinant hCG

  3. DHEA

    Time frame · 24 hours

    Registry description

    Assess serum levels of DHEA after stimulation with recombinant hCG

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 hours

17OHP Levels After hCG

GroupValue (ng/ml)Spread
PCOS Group3.20.5
Normal Group1.30.3
Oligomenorrhea Groupnot posted–
Secondary and other outcome results(3)
Secondary outcomeMean· 24 hours

Testosterone

GroupValue (ng/ml)Spread
PCOS Group1.60.2
Normal Group1.00.2
Oligomenorrhea Groupnot posted–
Secondary outcomeMean· 24 hours

Androstenedione

GroupValue (ng/ml)Spread
PCOS Group2.10.2
Normal Group0.90.2
Oligomenorrhea Groupnot posted–
Secondary outcomeMean· 24 hours

DHEA

GroupValue (ng/ml)Spread
PCOS Group1.60.2
Normal Group1.00.2
Oligomenorrhea Groupnot posted–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PCOS GroupIntervention: 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.0 / 140 / 140 / 14
Normal GroupIntervention: 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.0 / 100 / 100 / 10
Oligomenorrhea GroupNot included in the study0 / 00 / 00 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 12 Years up to 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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)

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