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

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ClinicalTrials.gov Identifier: NCT02155933
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Chris McCartney, University of Virginia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Puberty Hyperandrogenism Other: Blood sampling

Detailed Description:
Polycystic ovary syndrome (PCOS) is a common disorder marked by irregular ovulation and hyperandrogenism. Hyperandrogenemia during adolescence can be a forerunner of adult PCOS. However, the progression of hormonal abnormalities leading to PCOS are unclear. We will examine hormonal profiles (e.g., LH, FSH, progesterone, testosterone, estradiol) during pubertal maturation in adolescent girls with and without elevated plasma androgens. The working hypothesis is that, in pubertal girls without hyperandrogenemia, overnight rises of progesterone are associated with a reduction of LH frequency during the waking morning hours. However, in pubertal girls with hyperandrogenemia, LH frequency will be higher than normal during both the day and night, despite similar or higher progesterone levels. The studies will involve frequent blood sampling over 18 hours. We will assess differences in hormone parameters between time blocks (1900-2300 h, 2300-0300 h, 0300-0700 h, 0700-1100 h) in individuals to evaluate day-night changes. We will compare such changes between those with hyperandrogenemia and those without hyperandrogenemia.
Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Day-night Secretion of Progesterone and LH Across Pubertal Maturation in Girls With and Without Hyperandrogenemia (JCM023)
Study Start Date : February 2008
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Puberty

Groups and Cohorts
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Group/Cohort Intervention/treatment
Hyperandrogenemia
Peripubertal girls with hyperandrogenemia
 Other: Blood sampling
Blood sampling for later hormone measurements
Controls
Peripubertal girls without hyperandrogenemia
 Other: Blood sampling
Blood sampling for later hormone measurements


Outcome Measures
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Primary Outcome Measures :
  1. Difference in mean LH frequency when awake (19:00-23:00 and 07:00-11:00) and when asleep (23:00-07:00) in girls with and without hyperandrogenemia [ Time Frame: Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day). ]

Secondary Outcome Measures :
  1. Daytime (awake) and nighttime (sleep) differences in hormones (LH, FSH, T, E2, P, and cortisol) in girls with and without hyperandrogenemia [ Time Frame: Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day). ]

Biospecimen Retention:   Samples Without DNA
Serum Urine

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adolescent females
Criteria

Inclusion Criteria:

  • Early and late pubertal girls with normal androgens
  • Early and late pubertal girls with hyperandrogenemia
  • 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.

Exclusion Criteria:

  • Pregnancy
  • Inability to comprehend what will be done during the study or why it will be done
  • Hemoglobin <11.5 g/dL for non-African American subjects; Hemoglobin < 11.0 g/dL for African American subjects
  • Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
  • Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
  • Total bilirubin > 1.5 times upper limit of normal (i.e., confirmed on repeat)
  • Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
  • Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
  • Total testosterone > 200 ng/dl
  • Basal (follicular) 17-OHP > 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
  • DHEA-S > 800 mcg/dl
  • Elevation of prolactin > 2 times upper limit of normal
  • Weight less than 25 kg
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155933


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

Locations
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United States, Virginia
Center for Research in Reproduction, University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Melissa Gilrain    434-243-6911    pcos@virginia.edu   
Sub-Investigator: John C Marshall, MD         
Principal Investigator: Christopher McCartney, MD         
Sponsors and Collaborators
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Christopher R. McCartney, MD University of Virginia
More Information
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Responsible Party: Chris McCartney, Investigator, Center for Research in Reproduction, University of Virginia
ClinicalTrials.gov Identifier: NCT02155933    
Other Study ID Numbers: 13502
P50HD028934 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not have current plans to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperandrogenism
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
 Adrenogenital Syndrome
Congenital Abnormalities
Gonadal Disorders
Endocrine System Diseases