PULSE: Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS
Study Details
Study Description
Brief Summary
Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known. The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance. Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications. Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated. Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The goal of this study is to determine (using dietary restriction, exercise training, metformin or no treatment), the effects of weight loss and/or improved insulin sensitivity on reproductive function (neuroendocrine and ovarian) in obese women with Polycystic ovary syndrome.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
Other Names:
|
| Experimental: 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. |
Behavioral: 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 activity.
Other Names:
|
| Experimental: 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. |
Behavioral: 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.
Other Names:
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Luteinizing Hormone (LH) Pulse Frequency [Baseline and Week 24]
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.
Secondary Outcome Measures
- Insulin Sensitivity Expressed as Glucose Disposal Rate (GDR) [Baseline and Week 24]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
20 - 40 years, inclusive
-
Body mass index ≥ 25 kg/m2
-
History of irregular menstrual cycles (fewer than 6 cycles in the past year)
-
Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)
-
Anovulatory menstrual cycles (determined during screening)
Exclusion Criteria:
-
Ovulatory menstrual cycles (determined during screening by luteal phase serum progesterone >3ng/mL)
-
History or clinical appearance of cardiovascular disease, diabetes (Type 1 or Type 2) and any other significant reproductive, metabolic, hematologic, pulmonary, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer.
-
Hemoglobin, hematocrit, red blood cell count, or iron level below the lower limit of normal at the screening visit confirmed by a test repeated within two weeks
-
Regular use of medications for weight control, glucose intolerance, thyroid disease
-
Use of hormonal contraception containing medroxyprogesterone acetate (A 3 month washout period will be permitted for oral, vaginal and transdermal contraceptives).
Psychiatric and Behavioral Exclusion Criteria
-
Smoking
-
History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
-
History or presence of an eating disorder as determined by Interview for Diagnosis of Eating Disorders (IDED-IV)
-
Beck Depression Index (BDI) score of ≥15 at screening or baseline
Other Exclusion Criteria
-
Individuals who have lost more than 5kg (11lbs) in the past 6 months
-
Individuals who are pregnant or breast-feeding or whom become pregnant during the study
-
Individuals engaged in a regular program of physical fitness involving some heavy physical activity (e.g., jogging or riding fast on a bicycle for 30 minutes or more) at least five times per week over the past year
-
Individuals who have metallic objects in their body
-
Individuals who donated blood within 30 days prior to the date of randomization
-
Individuals unwilling to be assigned at random to either one of the intervention groups
-
Unwilling or unable to adhere to the rigors of the data collection (determined by food and activities diaries at screening, see below) and clinical evaluation schedule over the entire 24 week intervention period
-
Individuals who plan to move out of the area within the next 12 months or plan to be out of the study area for more than 4 weeks in the next 12 months
-
Individuals who reside too far from Pennington
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Pennington Biomedical Research Center
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Leanne M Redman, PhD, Pennington Biomedical Research Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Press Release: New Study at Pennington Biomedical Research Center Designed to Identify Factors Affecting Infertility in Women
- Study information and how to participate
Publications
None provided.- PBRC11016
- R00HD060762
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Metformin | Dietary Restriction | Exercise | Control |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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 | 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. | 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. |
| Period Title: Overall Study | ||||
| STARTED | 7 | 7 | 8 | 10 |
| COMPLETED | 4 | 4 | 4 | 5 |
| NOT COMPLETED | 3 | 3 | 4 | 5 |
Baseline Characteristics
| Arm/Group Title | Metformin | Dietary Restriction | Exercise | Control | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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. | 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 | 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. | 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 of all reporting groups |
| Overall Participants | 7 | 7 | 8 | 10 | 32 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
28.0
(5.0)
|
31.3
(6.2)
|
29.1
(3.8)
|
27.6
(5.6)
|
28.9
(5.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
7
100%
|
7
100%
|
8
100%
|
10
100%
|
32
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
3.1%
|
| Not Hispanic or Latino |
6
85.7%
|
6
85.7%
|
8
100%
|
9
90%
|
29
90.6%
|
| Unknown or Not Reported |
1
14.3%
|
1
14.3%
|
0
0%
|
0
0%
|
2
6.3%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
57.1%
|
6
85.7%
|
2
25%
|
6
60%
|
18
56.3%
|
| White |
3
42.9%
|
1
14.3%
|
6
75%
|
4
40%
|
14
43.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Luteinizing Hormone (LH) Pulse Frequency |
|---|---|
| Description | 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. |
| Time Frame | Baseline and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study stopped due to poor recruitment, enrollment, and retention. |
| Arm/Group Title | Metformin | Dietary Restriction | Exercise | Control |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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 | 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. | 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. |
| Measure Participants | 4 | 4 | 4 | 5 |
| Mean (Standard Deviation) [Number of pulses] |
-4.0
(11.3)
|
-1.5
(7.0)
|
-6.5
(13.4)
|
-3.0
(2.6)
|
| Title | Insulin Sensitivity Expressed as Glucose Disposal Rate (GDR) |
|---|---|
| Description | 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. |
| Time Frame | Baseline and Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Study stopped due to poor recruitment, enrollment, and retention. |
| Arm/Group Title | Metformin | Dietary Restriction | Exercise | Control |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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 | 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. | 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. |
| Measure Participants | 4 | 4 | 4 | 5 |
| Mean (Standard Deviation) [mg/kg/min] |
-1.8
(5.5)
|
1.0
(1.7)
|
0.8
(0.9)
|
22.4
(3.3)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Metformin | Dietary Restriction | Exercise | Control | ||||
| Arm/Group Description | 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. | 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 | 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. | 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. | ||||
All Cause Mortality |
||||||||
| Metformin | Dietary Restriction | Exercise | Control | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/7 (0%) | 0/7 (0%) | 0/8 (0%) | 0/10 (0%) | ||||
Serious Adverse Events |
||||||||
| Metformin | Dietary Restriction | Exercise | Control | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/7 (14.3%) | 0/7 (0%) | 0/8 (0%) | 0/10 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Hospitalized | 1/7 (14.3%) | 2 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Metformin | Dietary Restriction | Exercise | Control | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/7 (71.4%) | 5/7 (71.4%) | 5/8 (62.5%) | 8/10 (80%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anemia | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Blood Clot | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Cardiac disorders | ||||||||
| Edema | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Hypotension | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Ear and labyrinth disorders | ||||||||
| Earache | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 1/10 (10%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal Pain | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Constipation | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Diarrhea | 3/7 (42.9%) | 5 | 2/7 (28.6%) | 2 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Flatulence | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Nausea/Vomiting | 2/7 (28.6%) | 3 | 3/7 (42.9%) | 3 | 0/8 (0%) | 0 | 2/10 (20%) | 2 |
| Nonspecific | 1/7 (14.3%) | 1 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Stomach Virus | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| General disorders | ||||||||
| Headache/Migraine | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 2/8 (25%) | 2 | 1/10 (10%) | 1 |
| Fatigue | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Fever/Chills | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Flu-Like Symptoms | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Pain | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 1/10 (10%) | 1 |
| Nosebleed | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Sore Throat | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Nonspecific | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 1/10 (10%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Musculoskeletal Chest Pain | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Back Pain | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Arm Pain | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Sciatic Nerve Pain | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/10 (0%) | 0 |
| Neck/Shoulder Pain | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Ovarian Cyst | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/10 (0%) | 0 |
| Ovarian Cancer | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Menstrual Complaints | 1/7 (14.3%) | 1 | 2/7 (28.6%) | 2 | 1/8 (12.5%) | 1 | 1/10 (10%) | 1 |
| Ovarian Disorder | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Infection/Cystitis | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 2/10 (20%) | 2 |
| Vaginal Irritation | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Yeast Infection | 0/7 (0%) | 0 | 3/7 (42.9%) | 3 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Allergy Symptoms | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 2/10 (20%) | 2 |
| Upper Respiratory | 1/7 (14.3%) | 1 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Sinus Congestion | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 3/8 (37.5%) | 4 | 1/10 (10%) | 1 |
| Allergies | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Sinus Infection | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 1/8 (12.5%) | 1 | 0/10 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Hives | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Dry Skin | 1/7 (14.3%) | 1 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Blisters | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
| Rash | 0/7 (0%) | 0 | 1/7 (14.3%) | 1 | 0/8 (0%) | 0 | 0/10 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Dental Surgery | 0/7 (0%) | 0 | 0/7 (0%) | 0 | 0/8 (0%) | 0 | 1/10 (10%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Joshua R. Sparks |
|---|---|
| Organization | Pennington Biomedical Research Center |
| Phone | 2257632928 |
| joshua.sparks@pbrc.edu |
- PBRC11016
- R00HD060762