Trial Outcomes & Findings for Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea (NCT NCT00696111)
NCT ID: NCT00696111
Last Updated: 2024-12-31
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline
Results posted on
2024-12-31
Participant Flow
Participant milestones
| Measure |
Specific Aim 1
Baseline analysis comparing PCOS women with OSA to PCOS women without OSA.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Randomized to Receive Depot Lupron for 6 Weeks
|
18
|
|
Overall Study
Randomized to Receive Progesterone Plus Placebo for 6 Weeks
|
0
|
|
Overall Study
Randomized to Receive Continuous Positive Airway Pressure for 6 Weeks
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Specific Aim 1
Baseline analysis comparing PCOS women with OSA to PCOS women without OSA.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
Baseline Characteristics
Metabolic Study of Women With Polycystic Ovary Syndrome and Sleep Apnea
Baseline characteristics by cohort
| Measure |
Specific Aim 1
n=18 Participants
Baseline analysis comparing PCOS women with OSA to PCOS women without OSA.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The number of patients in Specific Aim 2 is zero, since the one patient randomized to Lupron dropped out.
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).
Outcome measures
| Measure |
Specific Aim 1: Women Without Obstructive Sleep Apnea
n=13 Participants
PCOS women without Obstructive Sleep Apnea
|
Specific Aim 1: Women With Obstructive Sleep Apnea
n=5 Participants
PCOS women with Obstructive Sleep Apnea
|
Specific Aim 2
Randomized 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.
|
Specific Aim 3
n=1 Participants
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
CPAP: CPAP (continuous positive airway pressure) treatment at home for six weeks.
|
|---|---|---|---|---|
|
Estrogen Levels
|
73.3 pg/ml
Standard Deviation 32.5
|
69.9 pg/ml
Standard Deviation 14.1
|
—
|
61.0 pg/ml
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients dropped out after randomization.
Sleep efficiency recorded with polysomnography minimum value = 0%, maximum value = 100%, higher values are a better outcome.
Outcome measures
| Measure |
Specific Aim 1: Women Without Obstructive Sleep Apnea
n=13 Participants
PCOS women without Obstructive Sleep Apnea
|
Specific Aim 1: Women With Obstructive Sleep Apnea
n=5 Participants
PCOS women with Obstructive Sleep Apnea
|
Specific Aim 2
Randomized 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.
|
Specific Aim 3
n=1 Participants
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
CPAP: CPAP (continuous positive airway pressure) treatment at home for six weeks.
|
|---|---|---|---|---|
|
Sleep Efficiency Measured at Baseline
|
93.2 Percentage
Standard Deviation 4.0
|
86.7 Percentage
Standard Deviation 7.0
|
—
|
92.3 Percentage
|
PRIMARY outcome
Timeframe: BaselinePopulation: patients dropped out after randomization
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).
Outcome measures
| Measure |
Specific Aim 1: Women Without Obstructive Sleep Apnea
n=13 Participants
PCOS women without Obstructive Sleep Apnea
|
Specific Aim 1: Women With Obstructive Sleep Apnea
n=5 Participants
PCOS women with Obstructive Sleep Apnea
|
Specific Aim 2
Randomized 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.
|
Specific Aim 3
n=1 Participants
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
CPAP: CPAP (continuous positive airway pressure) treatment at home for six weeks.
|
|---|---|---|---|---|
|
Total Testosterone
|
70.5 pg/ml
Standard Deviation 44.7
|
50.9 pg/ml
Standard Deviation 26.4
|
—
|
45.3 pg/ml
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients dropped out after randomization
Acute Insulin Response measured by the intravenous glucose tolerance test measured during baseline. The unit of measurement is mg/dl.
Outcome measures
| Measure |
Specific Aim 1: Women Without Obstructive Sleep Apnea
n=13 Participants
PCOS women without Obstructive Sleep Apnea
|
Specific Aim 1: Women With Obstructive Sleep Apnea
n=5 Participants
PCOS women with Obstructive Sleep Apnea
|
Specific Aim 2
Randomized 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.
|
Specific Aim 3
n=1 Participants
Randomized to receive CPAP (continuous positive airway pressure) treatment for 6 weeks.
CPAP: CPAP (continuous positive airway pressure) treatment at home for six weeks.
|
|---|---|---|---|---|
|
Intravenous Glucose Tolerance Test
|
938.5 mg/dl
Standard Deviation 770.1
|
730.6 mg/dl
Standard Deviation 478.1
|
—
|
189.5 mg/dl
|
Adverse Events
Specific Aim 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Specific Aim 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Specific Aim 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Karla Temple, Clinical Research Manager
University of Chicago
Phone: 773-702-3334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place