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

NCT02155933 | Unknown DMC

• 2 other identifiers: 13502P50HD028934
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Puberty; Hyperandrogenism

Outcome Measures

Primary Outcomes (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 for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day).

Secondary Outcomes (1)

• Daytime (awake) and nighttime (sleep) differences in hormones (LH, FSH, T, E2, P, and cortisol) in girls with and without hyperandrogenemia

  Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day).

Study Arms (2)

Hyperandrogenemia

Peripubertal girls with hyperandrogenemia

Other: Blood sampling

Controls

Peripubertal girls without hyperandrogenemia

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling for later hormone measurements

Controls; Hyperandrogenemia

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Adolescent females

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center for Research in Reproduction, University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Urine

MeSH Terms

Conditions

Hyperandrogenism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christopher R. McCartney, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Gilrain

CONTACT

434-243-6911; pcos@virginia.edu

Christopher R. McCartney, MD

CONTACT

434-243-6911; cm2hq@virginia.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, Center for Research in Reproduction

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 4, 2014
• Study Start: July 10, 2008
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)