Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
PCOS, Sleep Apnea and Metabolic Risk in Women
2 other identifiers
interventional
18
1 country
1
Brief Summary
The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in women with polycystic ovary syndrome (PCOS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedResults Posted
Study results publicly available
December 31, 2024
CompletedDecember 31, 2024
August 1, 2024
14.6 years
June 9, 2008
June 30, 2023
December 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Estrogen Levels
Estrogen levels measured every 20 minutes for 24 hours and the the average of those values are presented. The units of measurement are picograms per milliter (pg/ml).
Baseline
Sleep Efficiency Measured at Baseline
Sleep efficiency recorded with polysomnography minimum value = 0%, maximum value = 100%, higher values are a better outcome.
Baseline
Total Testosterone
Total Testosterone levels measured every 20 minutes for 24 hours and the average of those values are presented. The units of measurement are picograms per milliter (pg/ml).
Baseline
Secondary Outcomes (1)
Intravenous Glucose Tolerance Test
Baseline
Study Arms (1)
Depot Lupron and estrogen plus placebo
EXPERIMENTALRandomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
Interventions
A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of estrogen (2mg) plus placebo for six weeks.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of PCOS
- Obese (BMI of at least 30 kg/m2)
You may not qualify if:
- Diagnosis of nonclassic 21-hydroxylase deficiency, Cushing syndrome, hypothyroidism, or significant elevations in prolactin
- Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
- Positive pregnancy test
- Diagnosis of diabetes mellitus
- Hypertension (systolic \> 140 mmHg and/or diastolic \> 90 mmhg) not well-controlled on stable medication with either ACE inhibitors or diuretics
- Habitual alcohol use
- Excessive caffeine intake of more than 300 mg/day
- Known peanut allergies, or allergies to medications used in the study
- Hemoglobin \< 11g/dL and/or hematocrit \< 33%
- Systemic illnesses, including heart, renal, liver, or malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism
Chicago, Illinois, 60637, United States
Related Publications (6)
Hoffman LK, Ehrmann DA. Cardiometabolic features of polycystic ovary syndrome. Nat Clin Pract Endocrinol Metab. 2008 Apr;4(4):215-22. doi: 10.1038/ncpendmet0755. Epub 2008 Feb 5.
PMID: 18250636BACKGROUNDTasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. doi: 10.1073/pnas.0706446105. Epub 2008 Jan 2.
PMID: 18172212BACKGROUNDDronavalli S, Ehrmann DA. Pharmacologic therapy of polycystic ovary syndrome. Clin Obstet Gynecol. 2007 Mar;50(1):244-54. doi: 10.1097/GRF.0b013e31802f35a0.
PMID: 17304039BACKGROUNDEhrmann DA, Liljenquist DR, Kasza K, Azziz R, Legro RS, Ghazzi MN; PCOS/Troglitazone Study Group. Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):48-53. doi: 10.1210/jc.2005-1329. Epub 2005 Oct 25.
PMID: 16249284BACKGROUNDTasali E, Van Cauter E, Ehrmann DA. Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):36-42. doi: 10.1210/jc.2005-1084. Epub 2005 Oct 11.
PMID: 16219719BACKGROUNDTasali E, Chapotot F, Leproult R, Whitmore H, Ehrmann DA. Treatment of obstructive sleep apnea improves cardiometabolic function in young obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Feb;96(2):365-74. doi: 10.1210/jc.2010-1187. Epub 2010 Dec 1.
PMID: 21123449DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karla Temple, Clinical Research Manager
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
David A Ehrmann, MD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 12, 2008
Study Start
December 1, 2007
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
December 31, 2024
Results First Posted
December 31, 2024
Record last verified: 2024-08