Trial Outcomes & Findings for Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy (NCT NCT00245518)
NCT ID: NCT00245518
Last Updated: 2017-10-13
Results Overview
the NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.
COMPLETED
PHASE4
39 participants
baseline, 6 weeks, 12 weeks
2017-10-13
Participant Flow
39 participants were enrolled in this study. 3 were not randomized due to failed screening on laboratory assessment, 2 because they withdrew due to personal reasons, and 1 because of dislike of the taste of the compound.
Participant milestones
| Measure |
Isoflavone
Isoflavone
Isoflavone
|
Placebo
Placebos
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy
Baseline characteristics by cohort
| Measure |
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
Placebo
n=16 Participants
Placebos
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= 21 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksthe NART estimates intelligence levels of English-speaking patients. It consists of 50 short words with irregular spelling or phonetic appearance which the participant must read and pronounce. The higher the score, the higher number of correct responses. Scores are 0-50.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognitive Function as Assessed by the National Adult Reading Test (NART)
Baseline
|
45.2 units on a scale
Standard Deviation 2.12
|
39.6 units on a scale
Standard Deviation 3.02
|
|
Cognitive Function as Assessed by the National Adult Reading Test (NART)
6 weeks
|
42.43 units on a scale
Standard Deviation 2.66
|
41.29 units on a scale
Standard Deviation 3.25
|
|
Cognitive Function as Assessed by the National Adult Reading Test (NART)
12 weeks
|
43.69 units on a scale
Standard Deviation 2.83
|
41.57 units on a scale
Standard Deviation 3.21
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
Baseline
|
24.67 units on a scale
Standard Deviation 1.67
|
21.6 units on a scale
Standard Deviation 1.26
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
6 weeks
|
24.87 units on a scale
Standard Deviation 1.57
|
22.53 units on a scale
Standard Deviation 0.96
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score
12 weeks
|
25.85 units on a scale
Standard Deviation 1.56
|
22.47 units on a scale
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, \& 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score= higher cognitive function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
Baseline
|
22.13 units on a scale
Standard Deviation 0.46
|
20.8 units on a scale
Standard Deviation 0.87
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
6 weeks
|
20.4 units on a scale
Standard Deviation 1
|
21.47 units on a scale
Standard Deviation 1
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index
12 weeks
|
22.77 units on a scale
Standard Deviation 0.53
|
22.67 units on a scale
Standard Deviation 0.67
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe test consists 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. Approximately 20-25 min later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives, 6 semantically related, and 6 semantically unrelated. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score ( -12) ; the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives.A higher score= higher cognitive function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
Baseline
|
100.88 units on a scale
Standard Deviation 5.98
|
89.82 units on a scale
Standard Deviation 5.84
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
6 weeks
|
94.31 units on a scale
Standard Deviation 2.38
|
94.08 units on a scale
Standard Deviation 4.3
|
|
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained
12 weeks
|
94.68 units on a scale
Standard Deviation 3.63
|
95.21 units on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe F-A-S Test, a subtest of the Neurosensory Center Comprehensive Examination for Aphasia (NCCEA), is a measure of phonemic word fluency, which is a type of verbal fluency. It assesses phonemic fluency by requesting an individual to orally produce as many words as possible that begin with the letters F, A, and S within a prescribed time frame (1 minute)
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognitive Function as Assessed by the F-A-S Test
Baseline
|
58.79 seconds
Standard Deviation 3.65
|
55.36 seconds
Standard Deviation 5.08
|
|
Cognitive Function as Assessed by the F-A-S Test
6 weeks
|
64.47 seconds
Standard Deviation 4.51
|
56.93 seconds
Standard Deviation 4.78
|
|
Cognitive Function as Assessed by the F-A-S Test
12 weeks
|
63.31 seconds
Standard Deviation 4.43
|
57.93 seconds
Standard Deviation 4.42
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole. A faster time, indicates greater cognitive functioning.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
Baseline
|
101.5 time in seconds
Standard Deviation 8.14
|
91.8 time in seconds
Standard Deviation 8.7
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
6 weeks
|
89.93 time in seconds
Standard Deviation 4.32
|
78.73 time in seconds
Standard Deviation 3.34
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)
12 weeks
|
90.75 time in seconds
Standard Deviation 6.05
|
83.8 time in seconds
Standard Deviation 5.72
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the non-dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
Baseline
|
115.43 time in seconds
Standard Deviation 9.75
|
112.8 time in seconds
Standard Deviation 11.25
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
6 weeks
|
98.86 time in seconds
Standard Deviation 7.76
|
89.2 time in seconds
Standard Deviation 3.05
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)
12 weeks
|
102.73 time in seconds
Standard Deviation 7.43
|
88.67 time in seconds
Standard Deviation 6.91
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
Baseline
|
0.64 number of times peg dropped
Standard Deviation 0.27
|
0.4 number of times peg dropped
Standard Deviation 0.19
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
6 weeks
|
0.14 number of times peg dropped
Standard Deviation 0.1
|
0.33 number of times peg dropped
Standard Deviation 0.21
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops
12 weeks
|
0.09 number of times peg dropped
Standard Deviation 0.09
|
0.2 number of times peg dropped
Standard Deviation 0.11
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe GPT assesses eye-hand coordination and motor speed and thus requires sensory motor integration and a high level of motor processing. The test apparatus consists of a square metal surface (10.1 cm2) with a 5 × 5 matrix of keyhole shaped holes in various orientations. The task requires the examinee to pick up the keyhole shaped peg (3 mm in diameter) individually from the well just above the 5 × 5 matrix of holes from left to right and top to bottom as quickly as possible using the dominant hand. Because the holes are in various orientations, examinees must manipulate each peg in their hand (usually between the index finger and thumb) so that the peg aligns with the orientation of the hole.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
Baseline
|
0.21 number of times peg dropped
Standard Deviation 0.11
|
0.6 number of times peg dropped
Standard Deviation 0.4
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
6 weeks
|
0.07 number of times peg dropped
Standard Deviation 0.07
|
0.4 number of times peg dropped
Standard Deviation 0.13
|
|
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops
12 weeks
|
0.45 number of times peg dropped
Standard Deviation 0.28
|
0.27 number of times peg dropped
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points: 1. Correct Image: placed properly (2 points), placed poorly (1 point) 2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point 3. Absent or not recognizable: 0 points Scale ranges 0-36. with 36 being greatest cognitive function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
Baseline
|
20.87 units on a scale
Standard Deviation 1.15
|
16.03 units on a scale
Standard Deviation 2.21
|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
6 weeks
|
24.33 units on a scale
Standard Deviation 1.4
|
22.33 units on a scale
Standard Deviation 1.62
|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall
12 weeks
|
25.92 units on a scale
Standard Deviation 1.52
|
25.13 units on a scale
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe test measures recognition memory for the elements of the Rey complex figure, and assesses the respondent's ability to use cues to retrieve information after 25-30 minutes. Scoring of drawings is based on the widely used 36-point scoring system. Each of the 18 scoring units is scored based on accuracy and placement criteria. Items of the figure can earn points: 1. Correct Image: placed properly (2 points), placed poorly (1 point) 2. Distorted or Incomplete Image, but recognizable: placed properly (1 point), placed poorly (1/2) point 3. Absent or not recognizable: 0 points Scale ranges 0-36, with 36 representing maximum cognition .
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
Baseline
|
20.37 units on a scale
Standard Deviation 1.44
|
23.07 units on a scale
Standard Deviation 1.43
|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
6 weeks
|
23.07 units on a scale
Standard Deviation 1.43
|
20.43 units on a scale
Standard Deviation 1.61
|
|
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall
12 weeks
|
24.42 units on a scale
Standard Deviation 1.79
|
24.27 units on a scale
Standard Deviation 2.04
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe WSFQ contains 17 items that assess the domains of sexual desire/libido (6 items), arousal (1 item), orgasm/erectile function (7 items), and satisfaction(3 items). A five-point Likert-type scale ranging from "always" to "never" is used to generate a total score and four domain scores. The possible range of total sexual function scores is 17 to 85. Higher scores indicate better sexual function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
Baseline
|
62.92 units on a scale
Standard Deviation 3.18
|
62 units on a scale
Standard Deviation 3.71
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
6 weeks
|
63.21 units on a scale
Standard Deviation 2.3
|
63.83 units on a scale
Standard Deviation 2.79
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score
12 weeks
|
59.7 units on a scale
Standard Deviation 3.39
|
67 units on a scale
Standard Deviation 3.68
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe domain of sexual desire/libido consists of 6 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 6-30. Higher scores indicate increased libido/sexual desire.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
Baseline
|
22.21 units on a scale
Standard Deviation 1.19
|
21.4 units on a scale
Standard Deviation 1.4
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
6 weeks
|
22.13 units on a scale
Standard Deviation 1.15
|
21.36 units on a scale
Standard Deviation 1.2
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido
12 weeks
|
21.42 units on a scale
Standard Deviation 1.28
|
22.93 units on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe domain of erectile function/orgasm consists of 7 items. A five-point Likert-type scale ranging from "always" to "never" is used to generate a score, ranging from 7-35. Higher scores indicate increased erectile function/achievement of orgasm.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
Baseline
|
26.83 units on a scale
Standard Deviation 1.35
|
26 units on a scale
Standard Deviation 1.24
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
6 weeks
|
26.29 units on a scale
Standard Deviation 1.14
|
25.92 units on a scale
Standard Deviation 1.44
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function
12 weeks
|
25.36 units on a scale
Standard Deviation 1.65
|
27.46 units on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe domains of arousal (1 item subscale of the WSFQ), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score for arousal. The higher the number (range 1-5), the more the participant is able to experience arousal.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
Baseline
|
3.92 units on a scale
Standard Deviation 0.33
|
3.79 units on a scale
Standard Deviation 0.37
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
6 weeks
|
4.36 units on a scale
Standard Deviation 0.23
|
4.13 units on a scale
Standard Deviation 0.27
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal
12 weeks
|
3.45 units on a scale
Standard Deviation 0.51
|
4.31 units on a scale
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe domains of satisfaction (3 items), is assessed using a five-point Likert-type scale ranging from "always" to "never" to generate the score, ranging from 3-15. The higher the number, the higher the level of satisfaction with sexual function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
Baseline
|
10.92 units on a scale
Standard Deviation 0.77
|
10.69 units on a scale
Standard Deviation 0.71
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
6 weeks
|
11 units on a scale
Standard Deviation 0.71
|
11.92 units on a scale
Standard Deviation 0.81
|
|
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification
12 weeks
|
11.75 units on a scale
Standard Deviation 0.68
|
12.5 units on a scale
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0-5 is awarded to each of the 15 questions which refer to the past 4 weeks only. The questions are split into the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. The total score ranges from 6-75 with 6 being minimal erectile function and 75 representing maximal erectile function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
Baseline
|
21.33 units on a scale
Standard Deviation 5.17
|
11.31 units on a scale
Standard Deviation 2.1
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
6 weeks
|
17.4 units on a scale
Standard Deviation 4.6
|
13.2 units on a scale
Standard Deviation 2.24
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score
12 weeks
|
17.08 units on a scale
Standard Deviation 5
|
15 units on a scale
Standard Deviation 3.29
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. Erectile function is one domain, making up 6 out of 15 questions. The score ranges from 1-30, with the lowest score representing minimal erectile function.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
Baseline
|
7.33 units on a scale
Standard Deviation 2.44
|
3.27 units on a scale
Standard Deviation 1.07
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
6 weeks
|
5.87 units on a scale
Standard Deviation 2.35
|
3.67 units on a scale
Standard Deviation 1.06
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function
12 weeks
|
5.85 units on a scale
Standard Deviation 2.44
|
4.53 units on a scale
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with intercourse. A score of 0-5 is awarded to each of the 3 questions which refer to the past 4 weeks only. The score rangers from 0-15, with a score of 0 indicating that no intercourse was attempted in the last 4 weeks, 1= almost or little to no sanctification, 15= very highly satisfied.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
Baseline
|
3.8 units on a scale
Standard Deviation 1.35
|
0.67 units on a scale
Standard Deviation 0.46
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
6 weeks
|
2.33 units on a scale
Standard Deviation 1.11
|
1.2 units on a scale
Standard Deviation 0.59
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction
12 weeks
|
2.15 units on a scale
Standard Deviation 1.25
|
1.53 units on a scale
Standard Deviation 0.74
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being satisfaction with orgasm. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 1-10, with a score of 0 indicating that no sexual stimulation or intercourse was attempted in the last 4 weeks, 1= almost never or never ejaculated, 10= almost always or always
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
Baseline
|
1.73 units on a scale
Standard Deviation 0.62
|
0.47 units on a scale
Standard Deviation 0.26
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
6 weeks
|
1.27 units on a scale
Standard Deviation 0.54
|
1.07 units on a scale
Standard Deviation 0.5
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function
12 weeks
|
1.46 units on a scale
Standard Deviation 0.87
|
1.13 units on a scale
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual desire. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very low or none at all, and 10 representing almost always/very high.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
Baseline
|
3.73 units on a scale
Standard Deviation 0.6
|
2.8 units on a scale
Standard Deviation 0.26
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
6 weeks
|
3.47 units on a scale
Standard Deviation 0.52
|
3.07 units on a scale
Standard Deviation 0.33
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire
12 weeks
|
3.54 units on a scale
Standard Deviation 0.57
|
2.93 units on a scale
Standard Deviation 0.34
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksIIEF Questionnaire is used for the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials, one domain being sexual satisfaction. A score of 0-5 is awarded to each of the 2 questions which refer to the past 4 weeks only. The score rangers from 2-10, with a score of 2 indicating very dissatisfied and 10 being very satisfied.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
Baseline
|
4.73 units on a scale
Standard Deviation 0.73
|
3.85 units on a scale
Standard Deviation 0.66
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
6 weeks
|
4.47 units on a scale
Standard Deviation 0.72
|
4.2 units on a scale
Standard Deviation 0.63
|
|
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction
12 weeks
|
4.08 units on a scale
Standard Deviation 0.61
|
4.64 units on a scale
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
Baseline
|
7.07 units on a scale
Standard Deviation 0.928
|
8.2 units on a scale
Standard Deviation 1.284
|
|
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
6 weeks
|
7.2 units on a scale
Standard Deviation 0.634
|
7.2 units on a scale
Standard Deviation 1.36
|
|
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)
12 weeks
|
7.31 units on a scale
Standard Deviation 1.195
|
7.4 units on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksHot flashes were assessed using symptom severity 0= none, slight=1, moderate=2, and severe = 3. Hot flashes have a weighting factor of 4 on the overall Blatt-Kuppermann index, making score ranges 0-12, with 12 being the most severe hot flashes.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
Baseline
|
4.53 units on a scale
Standard Deviation 0.729
|
7 units on a scale
Standard Deviation 0.941
|
|
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
6 weeks
|
5 units on a scale
Standard Deviation 1.013
|
6.43 units on a scale
Standard Deviation 1.212
|
|
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)
12 weeks
|
4.38 units on a scale
Standard Deviation 0.903
|
7 units on a scale
Standard Deviation 0.845
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Mental Health as Assessed by the Short Form 36 Questionnaire
Baseline
|
81.23 units on a scale
Standard Deviation 4.62
|
69.67 units on a scale
Standard Deviation 7.16
|
|
Mental Health as Assessed by the Short Form 36 Questionnaire
6 weeks
|
77.37 units on a scale
Standard Deviation 4.64
|
71.36 units on a scale
Standard Deviation 5.62
|
|
Mental Health as Assessed by the Short Form 36 Questionnaire
12 weeks
|
80.66 units on a scale
Standard Deviation 4.87
|
77.18 units on a scale
Standard Deviation 4.02
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Physical Health as Assessed by the Short Form 36 Questionnaire
Baseline
|
76.25 units on a scale
Standard Deviation 5.59
|
64.25 units on a scale
Standard Deviation 6.17
|
|
Physical Health as Assessed by the Short Form 36 Questionnaire
6 weeks
|
74.73 units on a scale
Standard Deviation 4.38
|
65.75 units on a scale
Standard Deviation 6.56
|
|
Physical Health as Assessed by the Short Form 36 Questionnaire
12 weeks
|
72.36 units on a scale
Standard Deviation 5.45
|
66.92 units on a scale
Standard Deviation 5.63
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Fatigue as Assessed by the Short Form 36 Questionnaire
Baseline
|
64 units on a scale
Standard Deviation 5.65
|
50.67 units on a scale
Standard Deviation 8.24
|
|
Fatigue as Assessed by the Short Form 36 Questionnaire
6 weeks
|
63.67 units on a scale
Standard Deviation 4.1
|
49.67 units on a scale
Standard Deviation 7.28
|
|
Fatigue as Assessed by the Short Form 36 Questionnaire
12 weeks
|
67.69 units on a scale
Standard Deviation 4.62
|
54 units on a scale
Standard Deviation 5.88
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Physical Functioning as Assessed by the Short Form 36 Questionnaire
Baseline
|
83.33 units on a scale
Standard Deviation 5.53
|
71.67 units on a scale
Standard Deviation 9.41
|
|
Physical Functioning as Assessed by the Short Form 36 Questionnaire
6 weeks
|
82.14 units on a scale
Standard Deviation 4.41
|
71.33 units on a scale
Standard Deviation 6.96
|
|
Physical Functioning as Assessed by the Short Form 36 Questionnaire
12 weeks
|
84.23 units on a scale
Standard Deviation 3.34
|
78.33 units on a scale
Standard Deviation 8.07
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Body Pain as Assessed by the Short Form 36 Questionnaire
Baseline
|
78 units on a scale
Standard Deviation 5.37
|
66 units on a scale
Standard Deviation 6.2
|
|
Body Pain as Assessed by the Short Form 36 Questionnaire
6 weeks
|
74.33 units on a scale
Standard Deviation 5.93
|
73 units on a scale
Standard Deviation 7.33
|
|
Body Pain as Assessed by the Short Form 36 Questionnaire
12 weeks
|
76.35 units on a scale
Standard Deviation 5.31
|
74 units on a scale
Standard Deviation 6.48
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
General Health Perceptions as Assessed by the Short Form 36 Questionnaire
Baseline
|
63.37 units on a scale
Standard Deviation 5.24
|
56 units on a scale
Standard Deviation 3.94
|
|
General Health Perceptions as Assessed by the Short Form 36 Questionnaire
6 weeks
|
65.67 units on a scale
Standard Deviation 4.57
|
57 units on a scale
Standard Deviation 6.15
|
|
General Health Perceptions as Assessed by the Short Form 36 Questionnaire
12 weeks
|
61.54 units on a scale
Standard Deviation 5.2
|
58.67 units on a scale
Standard Deviation 4.77
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
Baseline
|
80 units on a scale
Standard Deviation 9.82
|
63.33 units on a scale
Standard Deviation 11.67
|
|
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
6 weeks
|
71.67 units on a scale
Standard Deviation 9.41
|
61.67 units on a scale
Standard Deviation 11.41
|
|
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire
12 weeks
|
67.31 units on a scale
Standard Deviation 12.46
|
56.67 units on a scale
Standard Deviation 10.76
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
Baseline
|
82.22 units on a scale
Standard Deviation 9.12
|
68.89 units on a scale
Standard Deviation 11.02
|
|
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
6 weeks
|
75.56 units on a scale
Standard Deviation 10.01
|
75.56 units on a scale
Standard Deviation 8.27
|
|
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
12 weeks
|
76.92 units on a scale
Standard Deviation 10.93
|
80 units on a scale
Standard Deviation 7.83
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksThe SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections: Vitality, Physical functioning, Bodily pain, General health perception, Physical role functioning, Emotional role functioning, Social role functioning, Mental health
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo
|
Isoflavone
n=17 Participants
Isoflavone
Isoflavone
|
|---|---|---|
|
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
Baseline
|
94.17 units on a scale
Standard Deviation 4.2
|
78.33 units on a scale
Standard Deviation 9
|
|
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
6 weeks
|
83.33 units on a scale
Standard Deviation 6.06
|
78.33 units on a scale
Standard Deviation 8.75
|
|
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire
12 weeks
|
89.42 units on a scale
Standard Deviation 3.7
|
88.33 units on a scale
Standard Deviation 5.38
|
Adverse Events
Isoflavone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Johns Hopkins University Clinical Trials Program
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place