Clinical trial · Interventional
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
PCOS, Sleep Apnea and Metabolic Risk in Women
NCT00696111CI-TRIAL-00084236completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obstructive Sleep Apnea | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Depot Lupron followed by estrogen plus placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Depot Lupron and estrogen plus placebo
- description
- Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
- interventionNames
- Drug: Depot Lupron followed by estrogen plus placebo
Primary outcomes (3)
- measure
- Estrogen Levels
- timeFrame
- Baseline
- description
- 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).
- measure
- Sleep Efficiency Measured at Baseline
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of PCOS * Obese (BMI of at least 30 kg/m2) Exclusion Criteria: * 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
References
Publications (6)
- BACKGROUNDHoffman 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 18250636
- BACKGROUNDTasali 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 18172212
- BACKGROUNDDronavalli S, Ehrmann DA. Pharmacologic therapy of polycystic ovary syndrome. Clin Obstet Gynecol. 2007 Mar;50(1):244-54. doi: 10.1097/GRF.0b013e31802f35a0. PMID 17304039
- BACKGROUNDEhrmann 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 16249284
- BACKGROUNDTasali 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 16219719
- DERIVEDTasali 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 21123449