RECRUITING

Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone

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Conditions

Polycystic Ovary SyndromeHyperandrogenismNormal Pubertyhyperandrogenemia

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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

During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time). The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.

Official Title

Suppression of Daytime and Nighttime LH Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia (JCM024)

Quick Facts

Study Start:2011-03-11
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01428089

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 14 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
  2. * Premenarcheal
  1. * Pregnancy
  2. * Inability to comprehend what will be done during the study or why it will be done
  3. * Hemoglobin less than 12 g/dl and hematocrit less than 36%
  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 thyroid-stimulating hormone (TSH) values
  9. * Total testosterone \> 200 ng/dl
  10. * Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
  11. * Dehydroepiandrosterone sulfate (DHEA-S) \> 800 mcg/dl
  12. * Elevation of prolactin \> 2 times upper limit of normal
  13. * Weight less than 26 kg.

Contacts and Locations

Study Contact

Melissa Gilrain
CONTACT
434-243-6911
pcos@virginia.edu
Christopher R McCartney, MD
CONTACT
434-243-6911
pcos@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 Date2011-03-11
Study Completion Date2024-12

Study Record Updates

Study Start Date2011-03-11
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • hyperandrogenemia

Additional Relevant MeSH Terms

  • Polycystic Ovary Syndrome
  • Hyperandrogenism
  • Normal Puberty