RECRUITING

Assessment of Day-night Secretion of Progesterone and LH Across Puberty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hormones are substances that are made by the body and are sent directly out into the bloodstream to increase or decrease the function of certain organs, glands, or other hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too much testosterone in their blood. Too much testosterone in the blood can possibly lead to a problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual periods, excess facial and body hair, and too much testosterone in their blood. On the other hand, some girls with too much testosterone in their blood do not develop PCOS. We do not know why some of these girls develop PCOS and why some do not. The purpose of this research study is to find out whether too much testosterone can cause problems with other hormones that can lead to the development of PCOS. This study may help us understand more about the causes of PCOS.

Official Title

Assessment of Day-night Secretion of Progesterone and LH Across Pubertal Maturation in Girls With and Without Hyperandrogenemia (JCM023)

Quick Facts

Study Start:2008-07-10
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02155933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 17 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Early and late pubertal girls with normal androgens
  2. * Early and late pubertal girls with hyperandrogenemia
  3. * All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair growth but at least 7 years old) to 7 years post menarche.
  1. * Pregnancy
  2. * Inability to comprehend what will be done during the study or why it will be done
  3. * Hemoglobin \<11.5 g/dL for non-African American subjects; Hemoglobin \< 11.0 g/dL for African American subjects
  4. * Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
  5. * Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
  6. * Total bilirubin \> 1.5 times upper limit of normal (i.e., confirmed on repeat)
  7. * Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
  8. * Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
  9. * Total testosterone \> 200 ng/dl
  10. * Basal (follicular) 17-OHP \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
  11. * DHEA-S \> 800 mcg/dl
  12. * Elevation of prolactin \> 2 times upper limit of normal
  13. * Weight less than 25 kg

Contacts and Locations

Study Contact

Melissa Gilrain
CONTACT
434-243-6911
pcos@virginia.edu
Christopher R. McCartney, MD
CONTACT
434-243-6911
cm2hq@virginia.edu

Principal Investigator

Christopher R. McCartney, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

Center for Research in Reproduction, University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Christopher R. McCartney, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-07-10
Study Completion Date2025-02

Study Record Updates

Study Start Date2008-07-10
Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

  • Puberty
  • Hyperandrogenism