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Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

Effect of Isoflavones on Cognition, Quality of Life and Hot Flashes in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245518
Enrollment
39
Registered
2005-10-28
Start date
2005-06-30
Completion date
2008-09-30
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes

Keywords

prostate cancer, soy, androgen deprivation, quality of life, isoflavones

Brief summary

This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

Detailed description

This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Interventions

DRUGPlacebos

Sponsors

Physicians Laboratories
CollaboratorUNKNOWN
National Cancer Institute (NCI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* men \> or =21 with prostate CA and hypogonadism for at least 3 months

Exclusion criteria

* on growth promoting agents * on appetite stimulating agents * on Prednisone and others

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Function as Assessed by the National Adult Reading Test (NART)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.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Scorebaseline, 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.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Indexbaseline, 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.
Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retainedbaseline, 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.
Cognitive Function as Assessed by the F-A-S Testbaseline, 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)
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)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.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)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.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Dropsbaseline, 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.
Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Dropsbaseline, 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.
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recallbaseline, 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.
Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recallbaseline, 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 .
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Scorebaseline, 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.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libidobaseline, 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.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Functionbaseline, 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.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousalbaseline, 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.
Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctificationbaseline, 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.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Scorebaseline, 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.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Functionbaseline, 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.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfactionbaseline, 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.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Functionbaseline, 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
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desirebaseline, 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.
Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfactionbaseline, 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.
Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)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'.
Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)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.
Mental Health as Assessed by the Short Form 36 Questionnairebaseline, 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
Physical Health as Assessed by the Short Form 36 Questionnairebaseline, 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
Fatigue as Assessed by the Short Form 36 Questionnairebaseline, 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
Physical Functioning as Assessed by the Short Form 36 Questionnairebaseline, 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
Body Pain as Assessed by the Short Form 36 Questionnairebaseline, 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
General Health Perceptions as Assessed by the Short Form 36 Questionnairebaseline, 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
Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnairebaseline, 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
Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnairebaseline, 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
Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnairebaseline, 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

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
Isoflavone
Isoflavone Isoflavone
17
Placebo
Placebos
16
Total33

Baseline characteristics

CharacteristicPlaceboTotalIsoflavone
Age, Customized
>= 21 years
16 Participants33 Participants17 Participants
Region of Enrollment
United States
16 Participants33 Participants17 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
16 Participants33 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 16
other
Total, other adverse events
0 / 170 / 16
serious
Total, serious adverse events
0 / 170 / 16

Outcome results

Primary

Body Pain as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBody Pain as Assessed by the Short Form 36 QuestionnaireBaseline78 units on a scaleStandard Deviation 5.37
PlaceboBody Pain as Assessed by the Short Form 36 Questionnaire6 weeks74.33 units on a scaleStandard Deviation 5.93
PlaceboBody Pain as Assessed by the Short Form 36 Questionnaire12 weeks76.35 units on a scaleStandard Deviation 5.31
IsoflavoneBody Pain as Assessed by the Short Form 36 QuestionnaireBaseline66 units on a scaleStandard Deviation 6.2
IsoflavoneBody Pain as Assessed by the Short Form 36 Questionnaire6 weeks73 units on a scaleStandard Deviation 7.33
IsoflavoneBody Pain as Assessed by the Short Form 36 Questionnaire12 weeks74 units on a scaleStandard Deviation 6.48
Primary

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)Baseline101.5 time in secondsStandard Deviation 8.14
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)6 weeks89.93 time in secondsStandard Deviation 4.32
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)12 weeks90.75 time in secondsStandard Deviation 6.05
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)6 weeks78.73 time in secondsStandard Deviation 3.34
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)12 weeks83.8 time in secondsStandard Deviation 5.72
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Dominant Hand Time (Seconds)Baseline91.8 time in secondsStandard Deviation 8.7
Primary

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)6 weeks98.86 time in secondsStandard Deviation 7.76
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)12 weeks102.73 time in secondsStandard Deviation 7.43
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)Baseline115.43 time in secondsStandard Deviation 9.75
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)Baseline112.8 time in secondsStandard Deviation 11.25
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)6 weeks89.2 time in secondsStandard Deviation 3.05
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Non-dominant Hand Time (Seconds)12 weeks88.67 time in secondsStandard Deviation 6.91
Primary

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand DropsBaseline0.64 number of times peg droppedStandard Deviation 0.27
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops6 weeks0.14 number of times peg droppedStandard Deviation 0.1
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops12 weeks0.09 number of times peg droppedStandard Deviation 0.09
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand DropsBaseline0.4 number of times peg droppedStandard Deviation 0.19
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops6 weeks0.33 number of times peg droppedStandard Deviation 0.21
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Dominant Hand Drops12 weeks0.2 number of times peg droppedStandard Deviation 0.11
Primary

Cognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand DropsBaseline0.21 number of times peg droppedStandard Deviation 0.11
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops6 weeks0.07 number of times peg droppedStandard Deviation 0.07
PlaceboCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops12 weeks0.45 number of times peg droppedStandard Deviation 0.28
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand DropsBaseline0.6 number of times peg droppedStandard Deviation 0.4
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops6 weeks0.4 number of times peg droppedStandard Deviation 0.13
IsoflavoneCognition as Assessed by the Grooved Pegboard Test (GPT) , Number of Non- Dominant Hand Drops12 weeks0.27 number of times peg droppedStandard Deviation 0.12
Primary

Cognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall

The 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 .

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed RecallBaseline20.37 units on a scaleStandard Deviation 1.44
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall6 weeks23.07 units on a scaleStandard Deviation 1.43
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall12 weeks24.42 units on a scaleStandard Deviation 1.79
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed RecallBaseline23.07 units on a scaleStandard Deviation 1.43
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall6 weeks20.43 units on a scaleStandard Deviation 1.61
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Delayed Recall12 weeks24.27 units on a scaleStandard Deviation 2.04
Primary

Cognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate RecallBaseline20.87 units on a scaleStandard Deviation 1.15
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall6 weeks24.33 units on a scaleStandard Deviation 1.4
PlaceboCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall12 weeks25.92 units on a scaleStandard Deviation 1.52
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate RecallBaseline16.03 units on a scaleStandard Deviation 2.21
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall6 weeks22.33 units on a scaleStandard Deviation 1.62
IsoflavoneCognition as Assessed by the Rex Complex Figure Test (RCFT), Immediate Recall12 weeks25.13 units on a scaleStandard Deviation 1.91
Primary

Cognitive Function as Assessed by the F-A-S Test

The 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)

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Function as Assessed by the F-A-S TestBaseline58.79 secondsStandard Deviation 3.65
PlaceboCognitive Function as Assessed by the F-A-S Test6 weeks64.47 secondsStandard Deviation 4.51
PlaceboCognitive Function as Assessed by the F-A-S Test12 weeks63.31 secondsStandard Deviation 4.43
IsoflavoneCognitive Function as Assessed by the F-A-S TestBaseline55.36 secondsStandard Deviation 5.08
IsoflavoneCognitive Function as Assessed by the F-A-S Test6 weeks56.93 secondsStandard Deviation 4.78
IsoflavoneCognitive Function as Assessed by the F-A-S Test12 weeks57.93 secondsStandard Deviation 4.42
Primary

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent RetainedBaseline100.88 units on a scaleStandard Deviation 5.98
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained6 weeks94.31 units on a scaleStandard Deviation 2.38
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained12 weeks94.68 units on a scaleStandard Deviation 3.63
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained6 weeks94.08 units on a scaleStandard Deviation 4.3
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent Retained12 weeks95.21 units on a scaleStandard Deviation 5.5
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Percent RetainedBaseline89.82 units on a scaleStandard Deviation 5.84
Primary

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination IndexBaseline22.13 units on a scaleStandard Deviation 0.46
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index6 weeks20.4 units on a scaleStandard Deviation 1
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index12 weeks22.77 units on a scaleStandard Deviation 0.53
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination IndexBaseline20.8 units on a scaleStandard Deviation 0.87
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index6 weeks21.47 units on a scaleStandard Deviation 1
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Recognition Discrimination Index12 weeks22.67 units on a scaleStandard Deviation 0.67
Primary

Cognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall ScoreBaseline24.67 units on a scaleStandard Deviation 1.67
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score6 weeks24.87 units on a scaleStandard Deviation 1.57
PlaceboCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score12 weeks25.85 units on a scaleStandard Deviation 1.56
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall ScoreBaseline21.6 units on a scaleStandard Deviation 1.26
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score6 weeks22.53 units on a scaleStandard Deviation 0.96
IsoflavoneCognitive Function as Assessed by the Hopkins Verbal Learning Test (HVLT), Total Recall Score12 weeks22.47 units on a scaleStandard Deviation 1.39
Primary

Cognitive Function as Assessed by the National Adult Reading Test (NART)

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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Function as Assessed by the National Adult Reading Test (NART)Baseline45.2 units on a scaleStandard Deviation 2.12
PlaceboCognitive Function as Assessed by the National Adult Reading Test (NART)6 weeks42.43 units on a scaleStandard Deviation 2.66
PlaceboCognitive Function as Assessed by the National Adult Reading Test (NART)12 weeks43.69 units on a scaleStandard Deviation 2.83
IsoflavoneCognitive Function as Assessed by the National Adult Reading Test (NART)Baseline39.6 units on a scaleStandard Deviation 3.02
IsoflavoneCognitive Function as Assessed by the National Adult Reading Test (NART)6 weeks41.29 units on a scaleStandard Deviation 3.25
IsoflavoneCognitive Function as Assessed by the National Adult Reading Test (NART)12 weeks41.57 units on a scaleStandard Deviation 3.21
Primary

Daytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)

The 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'.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)Baseline7.07 units on a scaleStandard Deviation 0.928
PlaceboDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)6 weeks7.2 units on a scaleStandard Deviation 0.634
PlaceboDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)12 weeks7.31 units on a scaleStandard Deviation 1.195
IsoflavoneDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)Baseline8.2 units on a scaleStandard Deviation 1.284
IsoflavoneDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)6 weeks7.2 units on a scaleStandard Deviation 1.36
IsoflavoneDaytime Sleepiness as Assessed by Epworth Sleepiness Scale (ESS)12 weeks7.4 units on a scaleStandard Deviation 1.05
Primary

Fatigue as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboFatigue as Assessed by the Short Form 36 QuestionnaireBaseline64 units on a scaleStandard Deviation 5.65
PlaceboFatigue as Assessed by the Short Form 36 Questionnaire6 weeks63.67 units on a scaleStandard Deviation 4.1
PlaceboFatigue as Assessed by the Short Form 36 Questionnaire12 weeks67.69 units on a scaleStandard Deviation 4.62
IsoflavoneFatigue as Assessed by the Short Form 36 QuestionnaireBaseline50.67 units on a scaleStandard Deviation 8.24
IsoflavoneFatigue as Assessed by the Short Form 36 Questionnaire6 weeks49.67 units on a scaleStandard Deviation 7.28
IsoflavoneFatigue as Assessed by the Short Form 36 Questionnaire12 weeks54 units on a scaleStandard Deviation 5.88
Primary

General Health Perceptions as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboGeneral Health Perceptions as Assessed by the Short Form 36 QuestionnaireBaseline63.37 units on a scaleStandard Deviation 5.24
PlaceboGeneral Health Perceptions as Assessed by the Short Form 36 Questionnaire6 weeks65.67 units on a scaleStandard Deviation 4.57
PlaceboGeneral Health Perceptions as Assessed by the Short Form 36 Questionnaire12 weeks61.54 units on a scaleStandard Deviation 5.2
IsoflavoneGeneral Health Perceptions as Assessed by the Short Form 36 QuestionnaireBaseline56 units on a scaleStandard Deviation 3.94
IsoflavoneGeneral Health Perceptions as Assessed by the Short Form 36 Questionnaire6 weeks57 units on a scaleStandard Deviation 6.15
IsoflavoneGeneral Health Perceptions as Assessed by the Short Form 36 Questionnaire12 weeks58.67 units on a scaleStandard Deviation 4.77
Primary

Hot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)

Hot 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)Baseline4.53 units on a scaleStandard Deviation 0.729
PlaceboHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)6 weeks5 units on a scaleStandard Deviation 1.013
PlaceboHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)12 weeks4.38 units on a scaleStandard Deviation 0.903
IsoflavoneHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)Baseline7 units on a scaleStandard Deviation 0.941
IsoflavoneHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)6 weeks6.43 units on a scaleStandard Deviation 1.212
IsoflavoneHot Flashes as Assessed by the Blatt-Kuppermann Index (Hot Flash Component)12 weeks7 units on a scaleStandard Deviation 0.845
Primary

Mental Health as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMental Health as Assessed by the Short Form 36 QuestionnaireBaseline81.23 units on a scaleStandard Deviation 4.62
PlaceboMental Health as Assessed by the Short Form 36 Questionnaire6 weeks77.37 units on a scaleStandard Deviation 4.64
PlaceboMental Health as Assessed by the Short Form 36 Questionnaire12 weeks80.66 units on a scaleStandard Deviation 4.87
IsoflavoneMental Health as Assessed by the Short Form 36 QuestionnaireBaseline69.67 units on a scaleStandard Deviation 7.16
IsoflavoneMental Health as Assessed by the Short Form 36 Questionnaire6 weeks71.36 units on a scaleStandard Deviation 5.62
IsoflavoneMental Health as Assessed by the Short Form 36 Questionnaire12 weeks77.18 units on a scaleStandard Deviation 4.02
Primary

Physical Functioning as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboPhysical Functioning as Assessed by the Short Form 36 Questionnaire12 weeks84.23 units on a scaleStandard Deviation 3.34
PlaceboPhysical Functioning as Assessed by the Short Form 36 QuestionnaireBaseline83.33 units on a scaleStandard Deviation 5.53
PlaceboPhysical Functioning as Assessed by the Short Form 36 Questionnaire6 weeks82.14 units on a scaleStandard Deviation 4.41
IsoflavonePhysical Functioning as Assessed by the Short Form 36 Questionnaire6 weeks71.33 units on a scaleStandard Deviation 6.96
IsoflavonePhysical Functioning as Assessed by the Short Form 36 QuestionnaireBaseline71.67 units on a scaleStandard Deviation 9.41
IsoflavonePhysical Functioning as Assessed by the Short Form 36 Questionnaire12 weeks78.33 units on a scaleStandard Deviation 8.07
Primary

Physical Health as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboPhysical Health as Assessed by the Short Form 36 QuestionnaireBaseline76.25 units on a scaleStandard Deviation 5.59
PlaceboPhysical Health as Assessed by the Short Form 36 Questionnaire6 weeks74.73 units on a scaleStandard Deviation 4.38
PlaceboPhysical Health as Assessed by the Short Form 36 Questionnaire12 weeks72.36 units on a scaleStandard Deviation 5.45
IsoflavonePhysical Health as Assessed by the Short Form 36 QuestionnaireBaseline64.25 units on a scaleStandard Deviation 6.17
IsoflavonePhysical Health as Assessed by the Short Form 36 Questionnaire6 weeks65.75 units on a scaleStandard Deviation 6.56
IsoflavonePhysical Health as Assessed by the Short Form 36 Questionnaire12 weeks66.92 units on a scaleStandard Deviation 5.63
Primary

Role Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 QuestionnaireBaseline82.22 units on a scaleStandard Deviation 9.12
PlaceboRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire6 weeks75.56 units on a scaleStandard Deviation 10.01
PlaceboRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire12 weeks76.92 units on a scaleStandard Deviation 10.93
IsoflavoneRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 QuestionnaireBaseline68.89 units on a scaleStandard Deviation 11.02
IsoflavoneRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire6 weeks75.56 units on a scaleStandard Deviation 8.27
IsoflavoneRole Limitations Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire12 weeks80 units on a scaleStandard Deviation 7.83
Primary

Role Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboRole Limitations Due to Physical Health as Assessed by the Short Form 36 QuestionnaireBaseline80 units on a scaleStandard Deviation 9.82
PlaceboRole Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire6 weeks71.67 units on a scaleStandard Deviation 9.41
PlaceboRole Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire12 weeks67.31 units on a scaleStandard Deviation 12.46
IsoflavoneRole Limitations Due to Physical Health as Assessed by the Short Form 36 QuestionnaireBaseline63.33 units on a scaleStandard Deviation 11.67
IsoflavoneRole Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire6 weeks61.67 units on a scaleStandard Deviation 11.41
IsoflavoneRole Limitations Due to Physical Health as Assessed by the Short Form 36 Questionnaire12 weeks56.67 units on a scaleStandard Deviation 10.76
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function

IIEF 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile FunctionBaseline7.33 units on a scaleStandard Deviation 2.44
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function6 weeks5.87 units on a scaleStandard Deviation 2.35
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function12 weeks5.85 units on a scaleStandard Deviation 2.44
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile FunctionBaseline3.27 units on a scaleStandard Deviation 1.07
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function6 weeks3.67 units on a scaleStandard Deviation 1.06
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Erectile Function12 weeks4.53 units on a scaleStandard Deviation 1.55
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction

IIEF 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse SatisfactionBaseline3.8 units on a scaleStandard Deviation 1.35
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction6 weeks2.33 units on a scaleStandard Deviation 1.11
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction12 weeks2.15 units on a scaleStandard Deviation 1.25
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction6 weeks1.2 units on a scaleStandard Deviation 0.59
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse SatisfactionBaseline0.67 units on a scaleStandard Deviation 0.46
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Intercourse Satisfaction12 weeks1.53 units on a scaleStandard Deviation 0.74
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function

IIEF 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic FunctionBaseline1.73 units on a scaleStandard Deviation 0.62
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function6 weeks1.27 units on a scaleStandard Deviation 0.54
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function12 weeks1.46 units on a scaleStandard Deviation 0.87
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function6 weeks1.07 units on a scaleStandard Deviation 0.5
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic FunctionBaseline0.47 units on a scaleStandard Deviation 0.26
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Orgasmic Function12 weeks1.13 units on a scaleStandard Deviation 0.47
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction

IIEF 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual SatisfactionBaseline4.73 units on a scaleStandard Deviation 0.73
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction6 weeks4.47 units on a scaleStandard Deviation 0.72
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction12 weeks4.08 units on a scaleStandard Deviation 0.61
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual SatisfactionBaseline3.85 units on a scaleStandard Deviation 0.66
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction6 weeks4.2 units on a scaleStandard Deviation 0.63
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Overall Sexual Satisfaction12 weeks4.64 units on a scaleStandard Deviation 0.86
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire

IIEF 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual DesireBaseline3.73 units on a scaleStandard Deviation 0.6
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire6 weeks3.47 units on a scaleStandard Deviation 0.52
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire12 weeks3.54 units on a scaleStandard Deviation 0.57
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire6 weeks3.07 units on a scaleStandard Deviation 0.33
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual DesireBaseline2.8 units on a scaleStandard Deviation 0.26
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Sexual Desire12 weeks2.93 units on a scaleStandard Deviation 0.34
Primary

Sexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score

IIEF 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score12 weeks17.08 units on a scaleStandard Deviation 5
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total ScoreBaseline21.33 units on a scaleStandard Deviation 5.17
PlaceboSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score6 weeks17.4 units on a scaleStandard Deviation 4.6
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total ScoreBaseline11.31 units on a scaleStandard Deviation 2.1
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score6 weeks13.2 units on a scaleStandard Deviation 2.24
IsoflavoneSexual Function as Assessed by the International Index of Erectile Function (IIEF) Questionnaire, Total Score12 weeks15 units on a scaleStandard Deviation 3.29
Primary

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), ArousalBaseline3.92 units on a scaleStandard Deviation 0.33
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal6 weeks4.36 units on a scaleStandard Deviation 0.23
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal12 weeks3.45 units on a scaleStandard Deviation 0.51
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), ArousalBaseline3.79 units on a scaleStandard Deviation 0.37
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal6 weeks4.13 units on a scaleStandard Deviation 0.27
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Arousal12 weeks4.31 units on a scaleStandard Deviation 0.31
Primary

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile FunctionBaseline26.83 units on a scaleStandard Deviation 1.35
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function6 weeks26.29 units on a scaleStandard Deviation 1.14
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function12 weeks25.36 units on a scaleStandard Deviation 1.65
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile FunctionBaseline26 units on a scaleStandard Deviation 1.24
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function6 weeks25.92 units on a scaleStandard Deviation 1.44
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Erectile Function12 weeks27.46 units on a scaleStandard Deviation 1.5
Primary

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), LibidoBaseline22.21 units on a scaleStandard Deviation 1.19
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido6 weeks22.13 units on a scaleStandard Deviation 1.15
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido12 weeks21.42 units on a scaleStandard Deviation 1.28
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), LibidoBaseline21.4 units on a scaleStandard Deviation 1.4
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido6 weeks21.36 units on a scaleStandard Deviation 1.2
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Libido12 weeks22.93 units on a scaleStandard Deviation 1.3
Primary

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification6 weeks11 units on a scaleStandard Deviation 0.71
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), SanctificationBaseline10.92 units on a scaleStandard Deviation 0.77
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification12 weeks11.75 units on a scaleStandard Deviation 0.68
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), SanctificationBaseline10.69 units on a scaleStandard Deviation 0.71
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification6 weeks11.92 units on a scaleStandard Deviation 0.81
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Sanctification12 weeks12.5 units on a scaleStandard Deviation 0.69
Primary

Sexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score

The 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.

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total ScoreBaseline62.92 units on a scaleStandard Deviation 3.18
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score6 weeks63.21 units on a scaleStandard Deviation 2.3
PlaceboSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score12 weeks59.7 units on a scaleStandard Deviation 3.39
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total ScoreBaseline62 units on a scaleStandard Deviation 3.71
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score6 weeks63.83 units on a scaleStandard Deviation 2.79
IsoflavoneSexual Function as Assessed by the Watts Sexual Function Questionnaire (WSFQ), Total Score12 weeks67 units on a scaleStandard Deviation 3.68
Primary

Social Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire

The 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

Time frame: baseline, 6 weeks, 12 weeks

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 QuestionnaireBaseline94.17 units on a scaleStandard Deviation 4.2
PlaceboSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire6 weeks83.33 units on a scaleStandard Deviation 6.06
PlaceboSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire12 weeks89.42 units on a scaleStandard Deviation 3.7
IsoflavoneSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 QuestionnaireBaseline78.33 units on a scaleStandard Deviation 9
IsoflavoneSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire6 weeks78.33 units on a scaleStandard Deviation 8.75
IsoflavoneSocial Functioning Due to Emotional Role Functioning as Assessed by the Short Form 36 Questionnaire12 weeks88.33 units on a scaleStandard Deviation 5.38

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026