Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02155933
Other study ID # 13502
Secondary ID P50HD028934
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2008
Est. completion date February 2025

Study information

Verified date November 2023
Source University of Virginia
Contact Melissa Gilrain
Phone 434-243-6911
Email pcos@virginia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 7 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling
Blood sampling for later hormone measurements

Locations

Country Name City State
United States Center for Research in Reproduction, University of Virginia Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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).
See also
  Status Clinical Trial Phase
Recruiting NCT05112029 - Metabolic Profile and Adipokine Levels in Young Hyperandrogenemic Females
Terminated NCT01428193 - Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone N/A
Enrolling by invitation NCT04485403 - The Effect of Ibuprofen on Women With PCOS. Phase 2
Active, not recruiting NCT00930007 - Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone
Completed NCT03252223 - Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS Phase 4
Terminated NCT02523898 - Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant Phase 2
Recruiting NCT04723862 - Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism? Early Phase 1
Suspended NCT02611128 - Urinary DENND1A.V2 as a Predictor of Pubertal Hyperandrogenemia
Recruiting NCT04453306 - Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome Phase 4
Recruiting NCT04979377 - Prevalence of Hyperandrogenism in Type 1 Diabetes
Recruiting NCT05926115 - Phenotype and Epidemiology of the Polycystic Ovary Syndrome (PCOS) in Colombia (PEP - Colombia) Study.
Active, not recruiting NCT01569425 - Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome N/A
Recruiting NCT01428089 - Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone Phase 1
Active, not recruiting NCT01421810 - Ovarian Contribution to Androgen Production in Adolescent Girls N/A
Completed NCT01313455 - Adrenal Hyperplasia Among Young People With PCOS
Completed NCT03188640 - Bariatric Surgery, Hormones, and Quality of Life N/A
Not yet recruiting NCT02402413 - Ultrasound Three-dimensional Characterization of Ovarian Morphology in Women With Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT02651636 - Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women N/A
Recruiting NCT00929006 - Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism Early Phase 1
Not yet recruiting NCT00665171 - Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome N/A