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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01421797
Other study ID # 12702
Secondary ID JCM022U54HD02893
Status Recruiting
Phase N/A
First received
Last updated
Start date October 10, 2006
Est. completion date March 2022

Study information

Verified date July 2018
Source University of Virginia
Contact Deborah M Sanderson, DC
Phone 434-243-6911
Email pcos@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date March 2022
Est. primary completion date March 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 7 Years to 18 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
1 mg PO
Cortrosyn
single IV bolus of 0.25 mg will be administered

Locations

Country Name City State
United States University of Virginia Center for Research in Reproduction Charlottesville Virginia

Sponsors (3)

Lead Sponsor Collaborator
University of Virginia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls. 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. Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).
Secondary Overnight changes in male and female hormones in response to ACTH suppression 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. 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)
Secondary Response to ACTH stimulation in normal weight and overweight girls Examine the differences in hormone responses to ACTH in normal weight and overweight girls. 14 hours (1900 - 0800 hrs)
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