Trial Outcomes & Findings for Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS (NCT NCT01482286)
NCT ID: NCT01482286
Last Updated: 2022-03-15
Results Overview
Change in Luteinizing Hormone (LH) Pulse Frequency measured over a 12-hour period (7:00 PM - 7:00 AM). The Mean and Standard Deviation (SD) are the number of pulses recorded on the 12-hour period (7:00 PM - 7:00 AM) and presented as the change from baseline to week 24. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention LF pulse frequency.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2022-03-15
Participant Flow
Participant milestones
| Measure |
Metformin
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
8
|
10
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS
Baseline characteristics by cohort
| Measure |
Metformin
n=7 Participants
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
n=7 Participants
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
n=8 Participants
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
n=10 Participants
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
27.6 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
28.9 years
STANDARD_DEVIATION 5.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Study stopped due to poor recruitment, enrollment, and retention.
Change in Luteinizing Hormone (LH) Pulse Frequency measured over a 12-hour period (7:00 PM - 7:00 AM). The Mean and Standard Deviation (SD) are the number of pulses recorded on the 12-hour period (7:00 PM - 7:00 AM) and presented as the change from baseline to week 24. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention LF pulse frequency.
Outcome measures
| Measure |
Metformin
n=4 Participants
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
n=4 Participants
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
n=4 Participants
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
n=5 Participants
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
|---|---|---|---|---|
|
Luteinizing Hormone (LH) Pulse Frequency
|
-4.0 Number of pulses
Standard Deviation 11.3
|
-1.5 Number of pulses
Standard Deviation 7.0
|
-6.5 Number of pulses
Standard Deviation 13.4
|
-3.0 Number of pulses
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Study stopped due to poor recruitment, enrollment, and retention.
Change in insulin sensitivity measured by the euglycemic hyperinsulinemic clamp. Unit of measure established as glucose disposal rate (GDR) adjusted to account for kilograms of fat-free mass (FFM)+17.7 per minute to reflect the amount of exogenous glucose necessary to fully compensate for hyperinsulinemia and expressed as a function of metabolic body size. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention Insulin Sensitivity expressed as Glucose Disposal Rate.
Outcome measures
| Measure |
Metformin
n=4 Participants
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
n=4 Participants
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
n=4 Participants
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
n=5 Participants
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
|---|---|---|---|---|
|
Insulin Sensitivity Expressed as Glucose Disposal Rate (GDR)
|
-1.8 mg/kg/min
Standard Deviation 5.5
|
1.0 mg/kg/min
Standard Deviation 1.7
|
0.8 mg/kg/min
Standard Deviation 0.9
|
22.4 mg/kg/min
Standard Deviation 3.3
|
Adverse Events
Metformin
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Dietary Restriction
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=7 participants at risk
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
n=7 participants at risk
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
n=8 participants at risk
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
n=10 participants at risk
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hospitalized
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
Other adverse events
| Measure |
Metformin
n=7 participants at risk
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
Metformin: Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
|
Dietary Restriction
n=7 participants at risk
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
Dietary Restriction: Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical ac
|
Exercise
n=8 participants at risk
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
Exercise Training: For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
|
Control
n=10 participants at risk
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen. Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
|
|---|---|---|---|---|
|
Cardiac disorders
Edema
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hives
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Blisters
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
3/7 • Number of events 5
|
28.6%
2/7 • Number of events 2
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
28.6%
2/7 • Number of events 3
|
42.9%
3/7 • Number of events 3
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Nonspecific
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Gastrointestinal disorders
Stomach Virus
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Menstrual Complaints
|
14.3%
1/7 • Number of events 1
|
28.6%
2/7 • Number of events 2
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian Disorder
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Infection/Cystitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal Irritation
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Yeast Infection
|
0.00%
0/7
|
42.9%
3/7 • Number of events 3
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cyst
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Blood Clot
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
0.00%
0/8
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sciatic Nerve Pain
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Neck/Shoulder Pain
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Headache/Migraine
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fever/Chills
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Flu-Like Symptoms
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
0.00%
0/10
|
|
General disorders
Pain
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Nosebleed
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Sore Throat
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Surgical and medical procedures
Dental Surgery
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergy Symptoms
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory
|
14.3%
1/7 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/7
|
14.3%
1/7 • Number of events 1
|
37.5%
3/8 • Number of events 4
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergies
|
0.00%
0/7
|
0.00%
0/7
|
0.00%
0/8
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/7
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Nonspecific
|
14.3%
1/7 • Number of events 1
|
0.00%
0/7
|
12.5%
1/8 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
Additional Information
Dr. Joshua R. Sparks
Pennington Biomedical Research Center
Phone: 2257632928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place