Trial Outcomes & Findings for Treating Inflammation in Polycystic Ovary Syndrome to Ameliorate Ovarian Dysfunction (NCT NCT03229408)
NCT ID: NCT03229408
Last Updated: 2025-06-10
Results Overview
Data was generated from the post-treatment HCG stimulation test. Area under the curve calculated for serum measurements by chemiluminescence (Siemens Immulite 2000, Cary, NC) from blood samples drawn 0, 24, 48 and 72 hours after HCG administration.
COMPLETED
PHASE2
60 participants
After 12 weeks of salsalate administration
2025-06-10
Participant Flow
Of the 60 volunteers enrolled, 35 of them never entered the protocol for the following reasons: Lost to follow up before screening completed during intermittent COVID-19 person-to-person human research suspensions (n=21); Declined study participation despite eligibility after screening (n=6); Ineligible after screening (n=8). The remaining 25 volunteers were entered into the study protocol.
Participant milestones
| Measure |
Experimental: Salsalate-Treated PCOS
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
Experimental: Salsalate-Treated PCOS
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Required to stopped during intermittent COVID-19 person-to-person human research suspensions
|
2
|
2
|
Baseline Characteristics
Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
Baseline characteristics by cohort
| Measure |
Experimental: Salsalate-Treated PCOS
n=14 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=11 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 Years
STANDARD_DEVIATION 4 • n=14 Participants
|
29 Years
STANDARD_DEVIATION 4 • n=11 Participants
|
28 Years
STANDARD_DEVIATION 4 • n=25 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=14 Participants
|
4 Participants
n=11 Participants
|
11 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=14 Participants
|
7 Participants
n=11 Participants
|
14 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
5 Participants
n=11 Participants
|
6 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=14 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=14 Participants
|
4 Participants
n=11 Participants
|
11 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
25 Participants
n=25 Participants
|
|
Body Mass Index
|
31.3 Kilos Per Meters Squared (kg/m2)
STANDARD_DEVIATION 5.9 • n=14 Participants
|
28.5 Kilos Per Meters Squared (kg/m2)
STANDARD_DEVIATION 6.4 • n=11 Participants
|
30.0 Kilos Per Meters Squared (kg/m2)
STANDARD_DEVIATION 6.2 • n=25 Participants
|
|
Total Body Fat
|
21981 Cubic Centimeters (cm3)
STANDARD_DEVIATION 5086 • n=13 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
18273 Cubic Centimeters (cm3)
STANDARD_DEVIATION 6720 • n=11 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
20282 Cubic Centimeters (cm3)
STANDARD_DEVIATION 6057 • n=24 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
|
Total Abdominal Fat
|
13710 Cubic Centimeters (cm3)
STANDARD_DEVIATION 4741 • n=13 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
11867 Cubic Centimeters (cm3)
STANDARD_DEVIATION 5322 • n=11 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
12865 Cubic Centimeters (cm3)
STANDARD_DEVIATION 4992 • n=24 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
|
Visceral Fat
|
3817 Cubic Centimeters (cm3)
STANDARD_DEVIATION 1390 • n=13 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
4487 Cubic Centimeters (cm3)
STANDARD_DEVIATION 5439 • n=11 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
4125 Cubic Centimeters (cm3)
STANDARD_DEVIATION 3740 • n=24 Participants • Only 13 participants assigned to the Experimental: Salsalate-Treated PCOS arm underwent magnetic resonance imaging. One (1) participant assigned to the Experimental: Salsalate-Treated PCOS arm who did not complete the study did not undergo magnetic resonance imaging due to the contradiction of having a copper intrauterine conception device in situ.
|
|
Basal Testosterone Level
|
70 Nanograms per Deciliter (ng/dL)
STANDARD_DEVIATION 9 • n=14 Participants
|
67 Nanograms per Deciliter (ng/dL)
STANDARD_DEVIATION 6 • n=11 Participants
|
69 Nanograms per Deciliter (ng/dL)
STANDARD_DEVIATION 8 • n=25 Participants
|
|
Basal Androstenedione Level
|
3.85 Nanograms per Milliliter (ng/mL)
STANDARD_DEVIATION 0.53 • n=14 Participants
|
3.66 Nanograms per Milliliter (ng/mL)
STANDARD_DEVIATION 0.46 • n=11 Participants
|
3.77 Nanograms per Milliliter (ng/mL)
STANDARD_DEVIATION 0.50 • n=25 Participants
|
|
HCG-stimulated Testosterone Area Under the Curve
|
7830 Nanograms*Hour per Deciliter (ng*hr/dL)
STANDARD_DEVIATION 1208 • n=14 Participants
|
7673 Nanograms*Hour per Deciliter (ng*hr/dL)
STANDARD_DEVIATION 1109 • n=11 Participants
|
7761 Nanograms*Hour per Deciliter (ng*hr/dL)
STANDARD_DEVIATION 1145 • n=25 Participants
|
|
HCG-stimulated Androstenedione Area Under the Curve
|
422 Nanograms*Hour per Milliliter (ng*hr/mL)
STANDARD_DEVIATION 69 • n=14 Participants
|
415 Nanograms*Hour per Milliliter (ng*hr/mL)
STANDARD_DEVIATION 40 • n=11 Participants
|
419 Nanograms*Hour per Milliliter (ng*hr/mL)
STANDARD_DEVIATION 57 • n=25 Participants
|
|
Insulin Sensitivity (SI)
|
2.86 Microunits/Milliliter/Minute (µU/mL/min)
STANDARD_DEVIATION 0.76 • n=6 Participants • Although 25 participants entered the protocol, baseline measures of insulin sensitivity are only provided for the 13 participants (6 salsalate arm; 7 placebo arm) with both pre- and post- treatment samples. Due to cost, pre-treatment samples from the 12 participants (8 salsalate arm; 4 placebo arm) without post-treatment samples to generate outcome data were not analyzed since this would not yield meaningful results to address the study aims, and there is no plan to analyze these in the future.
|
3.50 Microunits/Milliliter/Minute (µU/mL/min)
STANDARD_DEVIATION 0.63 • n=7 Participants • Although 25 participants entered the protocol, baseline measures of insulin sensitivity are only provided for the 13 participants (6 salsalate arm; 7 placebo arm) with both pre- and post- treatment samples. Due to cost, pre-treatment samples from the 12 participants (8 salsalate arm; 4 placebo arm) without post-treatment samples to generate outcome data were not analyzed since this would not yield meaningful results to address the study aims, and there is no plan to analyze these in the future.
|
3.20 Microunits/Milliliter/Minute (µU/mL/min)
STANDARD_DEVIATION 0.74 • n=13 Participants • Although 25 participants entered the protocol, baseline measures of insulin sensitivity are only provided for the 13 participants (6 salsalate arm; 7 placebo arm) with both pre- and post- treatment samples. Due to cost, pre-treatment samples from the 12 participants (8 salsalate arm; 4 placebo arm) without post-treatment samples to generate outcome data were not analyzed since this would not yield meaningful results to address the study aims, and there is no plan to analyze these in the future.
|
|
Lipid-stimulated ROS Generation
|
122 Percent Change
STANDARD_DEVIATION 43 • n=14 Participants
|
102 Percent Change
STANDARD_DEVIATION 41 • n=11 Participants
|
114 Percent Change
STANDARD_DEVIATION 42 • n=25 Participants
|
|
Lipid-stimulated NFкB Activation
|
93 Percent Change
STANDARD_DEVIATION 35 • n=14 Participants
|
134 Percent Change
STANDARD_DEVIATION 84 • n=11 Participants
|
111 Percent Change
STANDARD_DEVIATION 64 • n=25 Participants
|
|
Lipid-stimulated TNFα Secretion
|
13.1 Picograms per Milliliter (pg/mL)
STANDARD_DEVIATION 7.0 • n=14 Participants
|
14.0 Picograms per Milliliter (pg/mL)
STANDARD_DEVIATION 3.3 • n=11 Participants
|
13.5 Picograms per Milliliter (pg/mL)
STANDARD_DEVIATION 5.6 • n=25 Participants
|
PRIMARY outcome
Timeframe: After 12 weeks of salsalate administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment HCG stimulation test. Area under the curve calculated for serum measurements by chemiluminescence (Siemens Immulite 2000, Cary, NC) from blood samples drawn 0, 24, 48 and 72 hours after HCG administration.
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 1: HCG-stimulated Testosterone Area Under the Curve
|
4458 Nonograms*Hour per Deciliter (ng*hr/dL)
Standard Error 717
|
7775 Nonograms*Hour per Deciliter (ng*hr/dL)
Standard Error 539
|
PRIMARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment cream challenge test. Quantified in nuclear extracts by oligonucleotide-based ELISA (Active Motif, Carlsbad, CA) in mononuclear cells isolated from blood samples drawn while fasting (0 hour) and 2 hours after cream ingestion. Percent change was calculated using the 2 hour NFкB band intensity value determined by densitometry minus the 0 hour NFкB band intensity value divided by the 0 hour NFкB band intensity value, multiplied by 100.
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 2: Lipid-stimulated NFкB Activation
|
37 Percent Change
Standard Error 7
|
89 Percent Change
Standard Error 17
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo adminitrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment frequently-sampled intravenous glucose tolerance test (FS-IVGTT). Calculated using the Bergman minimal model (Am J Physiol 1979, 236:E667-E677) from serum insulin measurements using blood samples drawn while fasting at -20, -10, -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, 180 and 240 minutes.
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 1: Insulin Sensitivity (SI)
|
2.63 Microunits/Milliliter/Minute (µU/mL/min)
Standard Error 0.43
|
3.71 Microunits/Milliliter/Minute (µU/mL/min)
Standard Error 0.61
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Serum measurement by chemiluminescence (Siemens Immulite 2000, Cary, NC).
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 1: Basal Testosterone Level
|
38 Nanograms per Deciliter (ng/dL)
Standard Error 6
|
67 Nanograms per Deciliter (ng/dL)
Standard Error 3
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Serum measurement by ELISA (ALPCO Diagnostics, Salem, NH)
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 1: Basal Androstenedione Level
|
2.42 Nanograms per Milliliter (ng/mL)
Standard Error 0.54
|
3.69 Nanograms per Milliliter (ng/mL)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment HCG stimulation test. Area under the curve calculated for serum measurements by ELISA (ALPCO Diagnostics, Salem, NH) from blood samples drawn 0, 24, 48 and 72 hours after HCG administration.
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 1: HCG-stimulated Androstenedione Area Under the Curve
|
224 Nanograms*Hour per Milliliter (ng*hr/mL)
Standard Error 24
|
405 Nanograms*Hour per Milliliter (ng*hr/mL)
Standard Error 39
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment cream challenge test. Measured by chemiluminescence in mononuclear cells isolated from blood samples drawn while fasting (0 hour) and 2 hours after cream ingestion. Percent change was calculated using the 2 hour ROS value (mV) minus the 0 hour ROS value (mV) divided by the 0 hour ROS value (mV), multiplied by 100.
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 2: Lipid Stimulated ROS Generation
|
31 Percent Change
Standard Error 8
|
95 Percent Change
Standard Error 8
|
SECONDARY outcome
Timeframe: After 12 weeks of salsalate or placebo administrationPopulation: Only 13 of the 25 participants who entered the protocol completed the study consisting of 6 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 7 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm. The remaining 12 participants did not complete the study consisting of 8 participants assigned to the Experimental: Salsalate-Treated PCOS arm and 4 participants assigned to the Placebo Comparator: Placebo-Treated PCOS arm.
Data was generated from the post-treatment cream challenge test. Measured in culture supernatants by ELISA (Quantikine, R\&D Systems, Minneapolis, MN) in mononuclear cells isolated from blood samples drawn while fasting (0 hour) and 2 hours after cream ingestion. Absolute change was calculated using the 2 hour TNFα value (pg/mL) minus the 0 hour TNFα value (pg/mL).
Outcome measures
| Measure |
Experimental: Salsalate-Treated PCOS
n=6 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=7 Participants
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Aim 2: Lipid-stimulated TNFα Secretion
|
7.9 Picograms per Milliliter (pg/mL)
Standard Error 1.3
|
15.1 Picograms per Milliliter (pg/mL)
Standard Error 1.6
|
Adverse Events
Experimental: Salsalate-Treated PCOS
Placebo Comparator: Placebo-Treated PCOS
Serious adverse events
| Measure |
Experimental: Salsalate-Treated PCOS
n=14 participants at risk
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=11 participants at risk
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Immune system disorders
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome
|
7.1%
1/14 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
Other adverse events
| Measure |
Experimental: Salsalate-Treated PCOS
n=14 participants at risk
Lean PCOS (BMI 18.0-24.9 kg/m2): Salsalate 1.5 gm PO bid or Obese PCOS (BMI 30.0-39.9 kg/m2): Salsalate 2.0 gm PO bid
|
Placebo Comparator: Placebo-Treated PCOS
n=11 participants at risk
Lean PCOS (BMI 18.0-24.9 kg/m2) or Obese PCOS (BMI 30.0-39.9 kg/m2): Placebo appears identical to experimental drug
|
|---|---|---|
|
Immune system disorders
Medication Allergy - Urticaria
|
7.1%
1/14 • Number of events 1 • up to 16 weeks
|
0.00%
0/11 • up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place