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Trial record 2 of 2 for:    "Ovarian Cyst" | "Hydroxocobalamin"

Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT00670800
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : May 15, 2014
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Yolanda Smith, M.D., University of Michigan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Intervention Drug: Metformin
Enrollment 14
Recruitment Details Volunteers between the ages of 21 – 40 years were recruited from reproductive endocrinology clinic and newspapers. Women were excluded according to protocol exclusion criteria (see protocol)
Pre-assignment Details Some potential subjects were excluded due to results of an oral glucose tolerance test (OGTT).
Arm/Group Title Women Affected With PCOS - Metformin Women Controls Without PCOS
Hide Arm/Group Description The Polycystic Ovary Syndrome (PCOS) affected group is comprised of subjects with insulin resistant PCOS, defined as having irregular menstrual cycles and hyperandrogenism with other causes ruled out. Insulin resistance will be identified as fasting homeostasis model assessment insulin resistance (HOMA2-IR) of 60%S or less.

Control group is comprised of subjects without PCOS. These women have normal menstrual cycles and no evidence of insulin resistance (fasting HOMA2 IR of 80%S or more).

.

Exclusion criteria: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics).

Period Title: Overall Study
Started 7 7
Completed 7 5 [1]
Not Completed 0 2
Reason Not Completed
2 controls were insulin resistant             0             2
[1]
Two controls were found to have insulin resistance and were excluded from analysis.
Arm/Group Title PCOS Affected Women - Metformin Normal Controls Total
Hide Arm/Group Description Right handed women who don’t smoke and who drink very little will be considered eligible. Women with the following conditions (exclusion criteria) may not participate: left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, smoking within the last 6 months, use of hormones within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids (such as cortisol and prednisone), history of lactic acidosis (condition caused by the buildup of lactic acid in the body), heart, lung and kidney problems, liver disease, use of intravenous dyes, current cimetidine (Tagamet) use, use of medications that affect the brain (for example, codeine, anti-depressants, anti-psychotics). Normal controls are matched for age and education and screened for insulin resistance. Controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles, and lack hirsutism and acne. Exclusion criteria: Left handedness, acute medical illness, uncorrected thyroid disease, diabetes, neurological disease, current psychiatric illness, claustrophobia, contraindications to MRI (including pacemakers, pumps, surgical clips or metallic surgical devices), smoking within the last 6 months, use of hormones or insulin sensitizing mediation within the last 2 months, pregnancy within the last 6 months, current or past history of substance abuse, use of corticosteroids, cardiac or pulmonary insufficiency, active liver disease and transaminases elevations >2.5 X normal values, renal insufficiency (plasma creatinine level ≥1.4 mg/dl), use of centrally acting medications, allergy to any opioid medication, 300 lbs maximum weight limit (which is the max Total of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
Two controls were excluded from data analysis as they were later found to be insulin resistant.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
5
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 5 participants 12 participants
26.3  (4) 26.6  (4) 26.4  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
Female
7
 100.0%
5
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 5 participants 12 participants
7 5 12
Weight   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Pounds (lbs)
Number Analyzed 7 participants 5 participants 12 participants
203.9
(161 to 246.8)
123.7
(106 to 141.4)
170.48
(138.1 to 202.9)
[1]
Measure Description: Body weight measured in pounds (lbs)
BMI (Body Mass Index)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Lbs/inch^2
Number Analyzed 7 participants 5 participants 12 participants
35.3
(19.1 to 51.5)
23
(19.9 to 26.1)
29.5
(22.95 to 37.75)
[1]
Measure Description: lbs/inches squared (pounds over inches squared)
Waist Circumference   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 7 participants 5 participants 12 participants
102
(74.4 to 129.6)
72
(58.5 to 85.5)
92
(73.5 to 103.5)
[1]
Measure Description: Waist circumference measured in cm
Free Testosterone   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Pg/ml
Number Analyzed 7 participants 5 participants 12 participants
1.5
(0.6 to 2.4)
.5
(0.3 to 0.7)
1
(0.525 to 1.4)
[1]
Measure Description: Free testosterone measured in picograms over milliliters
Total Testosterone   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ng/ml
Number Analyzed 7 participants 5 participants 12 participants
.7
(.19 to 1.21)
.36
(.04 to .68)
.55
(.37 to .825)
[1]
Measure Description: Total Testosterone measured in nanograms over milliliters
Total Cholesterol   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mg/dl
Number Analyzed 7 participants 5 participants 12 participants
157
(111 to 203)
179
(119 to 239)
174
(140.25 to 195)
[1]
Measure Description: Total cholesterol measured in milligrams over deciliter
DHEAS   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Ug/dl
Number Analyzed 7 participants 5 participants 12 participants
200
(112 to 288)
189
(101 to 277)
191
(145 to 236.5)
[1]
Measure Description: Dehydroepiandrosterone Sulfate (DHEAS)measured in micrograms/deciliter
HDL   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mg/dl
Number Analyzed 7 participants 5 participants 12 participants
47
(30 to 64)
76
(52 to 100)
55.5
(47 to 76)
[1]
Measure Description: High-density lipoprotein measured in milligrams/deciliter
Triglycerides   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mg/dl
Number Analyzed 7 participants 5 participants 12 participants
74
(32 to 116)
72
(45 to 109)
73
(59.75 to 112.25)
[1]
Measure Description: Triglycerides measured in measured in milligrams/deciliter
Fasting Insulin   [1] 
Median (Inter-Quartile Range)
Unit of measure:  uU/ml
Number Analyzed 7 participants 5 participants 12 participants
21.4
(16.3 to 26.5)
8.1
(7.2 to 9)
17.25
(8.475 to 21.475)
[1]
Measure Description: Fasting Insulin measured in microunits/milliliter
Fasting Glucose   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Mg/dl
Number Analyzed 7 participants 5 participants 12 participants
87
(72 to 102)
89
(82 to 96)
89
(85.25 to 95.75)
[1]
Measure Description: Fasting Glucose measured in milligrams/deciliter
Homeostatic Model Assessment (HOMA)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  % - percentage
Number Analyzed 7 participants 5 participants 12 participants
36.6
(27.3 to 45.9)
95.4
(82.6 to 108.2)
46.65
(36.375 to 91.025)
[1]
Measure Description: Homeostatic model assessment sensitivity reported in percentage
HOMA-IR   [1] 
Median (Inter-Quartile Range)
Unit of measure:  mU/L
Number Analyzed 7 participants 5 participants 12 participants
2.7
(2.1 to 3.3)
1
(.8 to 1.2)
2.150
(1.1 to 2.775)
[1]
Measure Description: Homeostatic model assessment insulin resistance measured in milliunits per Liters
1.Primary Outcome
Title Mu-opioid Binding Potential Measured in Left Nucleus Accumbens
Hide Description

Mu-opioid binding potential in left nucleus accumbens is measured before and after 4 months of Metformin treatment.

Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.

Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)

Control group was measured at baseline only.

Time Frame Baseline and after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 7 PCOS women completed the protocol and were included. 5 of 7 controls were included in this analysis. 2 controls were excluded from analysis because repeat baseline OGTT showed HOMA %S of <80%.
Arm/Group Title PCOS Affected Women Pre-Metformin (Baseline) PCOS Affected Women Post-Metformin (After 4 Months) Normal Controls
Hide Arm/Group Description:
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
Overall Number of Participants Analyzed 7 7 5
Mean (Standard Deviation)
Unit of Measure: ratio
1.95  (0.17) 1.65  (.27) 1.53  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Post-Metformin (After 4 Months), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.900
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), PCOS Affected Women Post-Metformin (After 4 Months)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Mu-opioid Binding Potential Measured in Right Nucleus Accumbens
Hide Description

Mu-opioid binding potential in right nucleus accumbens measured before and after 4 months of Metformin treatment.

Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.

Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)

Control group was measured at baseline only.

Time Frame Baseline and after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
All 7 PCOS women were included, 2 controls were excluded because repeat baseline HOMA2-IR %S was <80%.
Arm/Group Title PCOS Affected Women Pre-Metformin (Baseline) PCOS Affected Women Post-Metformin (After 4 Months) Normal Control Women
Hide Arm/Group Description:
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
Overall Number of Participants Analyzed 7 7 5
Mean (Standard Deviation)
Unit of Measure: ratio
2.40  (.11) 2.11  (0.21) 2.05  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), Normal Control Women
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Post-Metformin (After 4 Months), Normal Control Women
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), PCOS Affected Women Post-Metformin (After 4 Months)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Mu-opioid Binding Potential Measured in Left Amygdala
Hide Description

Mu-opioid binding potential in left amygdala measured before and after 4 months of Metformin treatment.

Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.

Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)

Time Frame Baseline and after 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCOS Affected Women Pre-Metformin (Baseline) PCOS Affected Women Post-Metformin (After 4 Months) Normal Controls
Hide Arm/Group Description:
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
Overall Number of Participants Analyzed 7 7 5
Mean (Standard Deviation)
Unit of Measure: ratio
2.28  (.17) 2.08  (.19) 2.03  (.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.498
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Post-Metformin (After 4 Months), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.835
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), PCOS Affected Women Post-Metformin (After 4 Months)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Mu-opioid Binding Potential Measured in Right Amygdala
Hide Description

Mu-opioid binding potential in right amygdala measured before and after 4 months of Metformin treatment.

Mu-opioid binding potential is measured in vivo with C11-carfentanil positron emission tomography in women with PCOS before and after 4 months of metformin treatment.

Binding Potential is measured by the ratio of Mu-opioid receptor concentration (Bmax)/Receptor radiotracer (C11-carfentanil) affinity (Kd.)

Control group was measured at baseline only.

Time Frame Baseline and 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCOS Affected Women Pre-Metformin (Baseline) PCOS Affected Women Post-Metformin (After 4 Months) Normal Controls
Hide Arm/Group Description:
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
PCOS will be defined as meeting the criteria of irregular menstrual cycles and hyperandrogenism (on physical exam or laboratory testing), with other causes ruled out. Subjects with insulin resistant PCOS must meet criteria for insulin resistance based on the 2 hr OGTT (Oral Glucose Tolerance Test). Insulin resistance will be defined as fasting HOMA2 IR of 60%S or less.
Normal controls will have HOMA2 IR of 80%S or greater, normal hormone levels, regular menstrual cycles (range 24 - 34 days), and lack hirsutism and acne. Control subjects are matched for age and education with the PCOS affected women. Control data is measured once (at baseline time frame) for the entire study.
Overall Number of Participants Analyzed 7 7 5
Mean (Standard Deviation)
Unit of Measure: ratio
2.28  (.23) 2.11  (.22) 2.06  (.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Post-Metformin (After 4 Months), Normal Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PCOS Affected Women Pre-Metformin (Baseline), PCOS Affected Women Post-Metformin (After 4 Months)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse events were followed in the course of 2 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Controls PCOS Affected Women on Metformin
Hide Arm/Group Description Women without PCOS Women with PCOS and insulin resistance
All-Cause Mortality
Normal Controls PCOS Affected Women on Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Normal Controls PCOS Affected Women on Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Normal Controls PCOS Affected Women on Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      1/7 (14.29%)    
General disorders     
Nausea from Carfentanil at PET   1/5 (20.00%)  1 0/7 (0.00%)  0
Metabolism and nutrition disorders     
High Glucose During Oral Glucose Tolerance Test (OGTT)  [1]  0/5 (0.00%)  0 1/7 (14.29%)  1
Indicates events were collected by systematic assessment
[1]
OGTT after 3 ½ months of Metformin. This event was unexpected as Metformin is prescribed to reduce the blood sugar levels and is a widely accepted anti-diabetic drug.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Yolanda Smith
Organization: University of Michigan
Phone: (734) 936-7401
Responsible Party: Yolanda Smith, M.D., University of Michigan
ClinicalTrials.gov Identifier: NCT00670800     History of Changes
Other Study ID Numbers: 2276
HUM00008330 ( Other Identifier: The University of Michigan IRBMED )
First Submitted: April 30, 2008
First Posted: May 2, 2008
Results First Submitted: January 2, 2013
Results First Posted: May 15, 2014
Last Update Posted: May 21, 2014