Trial · Interventional

CompletedNot applicableResults postedRegistry data

Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea

NCTNCT00696111Other id15872BOther id1P50HD057796

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 18 participants (actual)
Sponsor: University of Chicago · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2007
Primary completion: 30 Jun 2022
Completion: 30 Jun 2022
First posted: 12 Jun 2008 (estimated)
Last update posted: 31 Dec 2024
Conditions: Polycystic Ovary Syndrome · Obstructive Sleep Apnea

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201020152020

N/A
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
NCT00696111
Dec 2007 to 30 Jun 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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).

Interventions

Depot Lupron followed by estrogen plus placeboDrug

Arms1

Experimental
Depot Lupron and estrogen plus placebo
Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive estrogen plus placebo for another 6 weeks.

Primary outcomes3

Outcomes the sponsor listed as primary.

Estrogen Levels
Time frame · Baseline
Registry 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).
Sleep Efficiency Measured at Baseline
Time frame · Baseline
Registry description
Sleep efficiency recorded with polysomnography minimum value = 0%, maximum value = 100%, higher values are a better outcome.
Total Testosterone
Time frame · Baseline
Registry description
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).

Secondary outcomes(1)

Intravenous Glucose Tolerance Test
Time frame · Baseline
Registry description
Acute Insulin Response measured by the intravenous glucose tolerance test measured during baseline. The unit of measurement is mg/dl.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline

Estrogen Levels

Group	Value (pg/ml)	Spread
Specific Aim 1: Women Without Obstructive Sleep Apnea	73.3	32.5
Specific Aim 1: Women With Obstructive Sleep Apnea	69.9	14.1
Specific Aim 2	not posted	–
Specific Aim 3	61.0	18.2

Primary outcomeMean· Baseline

Sleep Efficiency Measured at Baseline

Group	Value (Percentage)	Spread
Specific Aim 1: Women Without OSA	93.2	4.0
Specific Aim 1: Women With Obstructive Sleep Apnea	86.7	7.0
Specific Aim 2	not posted	–
Specific Aim 3	92.3	–

Primary outcomeMean· Baseline

Total Testosterone

Group	Value (pg/ml)	Spread
Specific Aim 1: Women Without Obstructive Sleep Apnea	70.5	44.7
Specific Aim 1: Women With Obstructive Sleep Apnea	50.9	26.4
Specific Aim 2	not posted	–
Specific Aim 3	45.3	14.8

Secondary and other outcome results(1)

Secondary outcomeMean· Baseline

Intravenous Glucose Tolerance Test

Group	Value (mg/dl)	Spread
Specific Aim 1:PCOS Women Without Obstructive Sleep Apnea	938.5	770.1
Specific Aim:1 PCOS Women With Obstructive Sleep Apnea	730.6	478.1
Specific Aim 2	not posted	–
Specific Aim3	189.5	–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Specific Aim 1Baseline analysis comparing PCOS women with OSA to PCOS women without OSA.	0 / 18	0 / 18	0 / 18
Specific Aim 2Randomized to receive depot Lupron for 6 weeks. Then randomized again to receive EITHER esgrogen plus placebo OR progesterone plus placebo for another 6 weeks. 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. 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.	0 / 0	0 / 0	0 / 0
Specific Aim 3Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks. CPAP: CPAP (continuous positive airway pressure) treatment at home for six weeks.	0 / 1	0 / 1	0 / 1

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

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

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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