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

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02155933
Study type	Observational
Source	University of Virginia
Contact	Melissa Gilrain
Phone	434-243-6911
Email	pcos@virginia.edu
Status	Recruiting
Phase
Start date	July 10, 2008
Completion date	February 2025

View Details

See also
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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
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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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms