Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
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ClinicalTrials.gov Identifier: NCT00696111 |
Recruitment Status :
Active, not recruiting
First Posted : June 12, 2008
Last Update Posted : October 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome Obstructive Sleep Apnea | Drug: Depot Lupron followed by estrogen plus placebo Drug: Depot Lupron followed by progesterone plus placebo. Device: CPAP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PCOS, Sleep Apnea and Metabolic Risk in Women |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: 1A
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.
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Drug: Depot Lupron followed by estrogen plus placebo
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. |
Experimental: 1B
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive progesterone plus placebo for another 6 weeks.
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Drug: Depot Lupron followed by progesterone plus placebo.
A single intramuscular dose of depot lupron (11.25 mg). Six weeks after injection, subjects will receive daily oral doses of progesterone (200mg) plus placebo for six weeks. |
Experimental: 3
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
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Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for six weeks. |
- Sex steroid levels [ Time Frame: After treatment (6 weeks) ]
- Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ]
- Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ]
- 24-hour hormonal profiles [ Time Frame: After treatment (6 weeks) ]

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696111
United States, Illinois | |
University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | David A Ehrmann, MD | University of Chicago |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00696111 |
Other Study ID Numbers: |
15872B 1P50HD057796 ( U.S. NIH Grant/Contract ) |
First Posted: | June 12, 2008 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
PCOS OSA Metabolism Diabetes |
Polycystic Ovary Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Syndrome Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Ovarian Cysts |
Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Leuprolide Progesterone Estrogens Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents |