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Trial · Interventional

Status unknownNot applicableRegistry data

Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

NCTNCT01421797 (opens ClinicalTrials.gov in a new tab)Other id12702Other idJCM022Other idU54HD028934-18Other id12702
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Overview

Status
Status unknown
Phase
Not applicable
Enrollment
84 participants (estimated)
Sponsor
University of Virginia · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
10 Oct 2006
Primary completion
27 Aug 2024 (estimated)
Completion
Dec 2024 (estimated)
First posted
23 Aug 2011 (estimated)
Last update posted
27 Oct 2023
Conditions
Hyperandrogenemia · Polycystic Ovary Syndrome · Obesity

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201520202025
  1. N/A

    Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation

    NCT01421797

    10 Oct 2006 to est. Dec 2024

Registry summary

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

Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.

Interventions

  • DexamethasoneDrug
  • CortrosynDrug

Arms1

  • Experimental

    Dexamethasone, Cortrosyn

    Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

    Time frame · Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).

    Registry description

    A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.

Secondary outcomes(2)

  1. Overnight changes in male and female hormones in response to ACTH suppression

    Time frame · 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)

    Registry description

    Secondary endpoints will include overnight changes in testosterone, estradiol, cortisol, dehydroepiandrosterone (DHEA), and luteinizing hormone (LH) pulse patterns in response to adrenocorticotropic hormone (ACTH) suppression. These secondary endpoints will be evaluated in a similar manner to the primary endpoint.

  2. Response to ACTH stimulation in normal weight and overweight girls

    Time frame · 14 hours (1900 - 0800 hrs)

    Registry description

    Examine the differences in hormone responses to ACTH in normal weight and overweight girls.

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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 7 Years up to 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Normal and obese (\>95th BMI%) females * Weight of 24 kg or more * Early to late puberty (expected age range 7-18) * Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG) Exclusion Criteria: * Screening labs outside of age-appropriate normal range * Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.) * Morning Cortisol \<5 g/dL * 17-hydroxyprogesterone \>295 ng/dL * Weight\<24 kg * History of Cushing's syndrome or adrenal insufficiency * Pregnant (self reported)

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