View Clinical Trial (Medical Research Study)


Ovarian Contribution to Androgen Production in Adolescent Girls

Signup
Browse Studies

City:   Charlottesville
State:   Virginia
Zip Code:   22908
Conditions:   Polycystic Ovary Syndrome - Obesity - Hyperandrogenism
Purpose:   Women with Polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
Study Summary:  
Criteria:   Inclusion Criteria: - Girls age 7-18 years - Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile) - With or without signs of excess androgen - 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 FSH and/or SHBG Exclusion Criteria: - Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR12702/JCM022. This protocol is designed to allow subjects enrolling in IRB-HSR12702/JCM022 to simultaneously participate in this companion protocol. - Inability to comprehend what will be done during the study or why it will be done - BMI-for-age < 5th percentile - Weight < 27 kg if simultaneously participating in IRB-HSR12702/JCM022 due to blood volume limits - Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome) - Since the study involves looking at ovarian function, boys will be excluded. - Positive pregnancy test or lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage them to tell their parent(s) and counsel them about the importance of appropriate prenatal care and counseling. We will arrange follow-up for them at the Teen Health Clinic at the University of Virginia or their primary care physician's office in a timely manner. - Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error. - Morning cortisol < 3 microgram/dL or history of Cushing syndrome or adrenal insufficiency - History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL, which suggests the possibility of congenital adrenal hyperplasia (if postmenarchal, the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300 mg/dL is confirmed on repeat testing, an ACTH-stimulated 17-hydroxyprogesterone <1000 ng/dL will be required for study participation. - Total testosterone > 150 ng/dL - Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5% - Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded. - Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations <1.5 times the upper limit of normal will be accepted in this group. - Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous gluconate daily (containing 36 mg elemental iron); subjects weighing >36 kg will take two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron each). They will return to the CRU or alternate UVA clinical unit after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked and will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%, respectively. - Persistent liver test abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild elevations may be seen in overweight girls, so elevations <1.5 times the upper limit of normal will be accepted in this group.
NCT ID:   NCT01421810
Primary Contact:   Principal Investigator
Christine Burt Solorzano, MD
University of Virginia Center for Research in Reproduction

Michelle Y. Abshire, PhD
Phone: 434-243-6911
Email: pcos@virginia.edu
Backup Contact:   Email: pcos@virginia.edu
Christine Burt Solorzano, MD
Phone: 434-243-6911
Location Contact:   Charlottesville, Virginia 22908
United States

Michelle Y Abshire, PhD
Phone: 434-243-6911
Email: pcos@virginia.edu

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   September 02, 2014
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
Click to view Full Listing


If you would like to be contacted by the clinical trial representative please enter your contact information, then click I Am Interested In This Study

Full Name:
 
Email Address:
Confirm Email:
Daytime Phone (eg. 555-555-5555):
City:
State:
Zip Code:
Best Time to Call:
Questions/Comments:
  • NEARBY STUDIES

    (updated 9 minutes ago)
Within 25 Miles

Within 50 Miles

Within 100 Miles

Endometriosis - Washington DC

Endometriosis - Richmond VA

Endometriosis - Richmond VA

Multiple Sclerosis (Relapsing) - Roanoke VA

Pediatric Depression - Richmond VA

Asthma - Henrico VA

Adolescent Major Depression (Ages 12-17) - Richmond VA

Heart Failure After Heart Attack - Richmond VA

Type II Diabetes and Cardiovascular Disease - Richmond VA

Type II Diabetes - Richmond VA

Chronic Pain and Opioid Induced Constipation - Richmond VA

Dust Mite Allergy - Henrico VA

Chronic Idiopathic Constipation - Richmond VA

Eczema - Richmond VA

Pediatric Asthma - Richmond VA

Severe Asthma - Richmond VA

Children with Asthma - Richmond VA

Endometriosis - Richmond VA

Multiple Sclerosis - Washington DC

Asthma - Richmond VA

Endometriosis - Richmond VA

Postmenopausal Osteoporosis - Richmond VA

Type 2 Diabetes - Winchester VA

Type 2 Diabetes - Richmond VA

Type 2 Diabetes - Oxon Hill MD

Type 2 Diabetes - Manassas VA

Diabetic Gastroparesis - Manassas VA

Diabetic Gastroparesis - Burke VA

Weight Management and Cardiovascular Disease - Henrico VA

High Cholesterol - Burke VA

High Cholesterol - Manassas VA

Polycystic Kidney Disease (PKD) - Autosomal Dominant (ADPKD) - Arlington VA

COPD (Emphysema and Chronic Bronchitis) - Richmond VA

COPD (Emphysema and Chronic Bronchitis) - Richmond VA

Type 2 Diabetes - Sterling VA

Asthma in Children (Ages 5-11) - Burke VA

High Cholesterol - Oxon Hill MD

Adolescent Schizophrenia - Petersburg VA

Asthma - Fairfax VA

Children and Adolescents with Bipolar Disorder - Petersburg VA