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Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer
Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subjects receive supplement |
|
| 2 | Placebo Comparator | Subjects will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flav-ein capsules | Dietary Supplement | Soy/isoflavone supplementation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens | 16 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M. Holzbeierlein, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
Study was terminated early due to low accrual. Study was blinded and no data was collected
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1/ Soy Supplementation | Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation |
| FG001 | Arm 2/ Placebo | Subjects will receive placebo Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This trial was stopped early due to low enrollment. There was not a sufficient number of participants to accurately analyze the data. Randomization was not completed prior to termination. Data for population analysis not collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1/ Soy Supplementation | Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation |
| BG001 | Arm 2/ Placebo | Subjects will receive placebo Placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens | The trial was stopped early due to failure to accrue Not enough subjects were enrolled with enough follow up to have data | Posted | 16 Weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flav-ein Capsules | Subjects receive supplement Flav-ein capsules: Soy/isoflavone supplementation |
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Early termination due to low accrual. Insufficient number of participants for accurate analysis. No data collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Holzbeierlein, MD, FACS | The University of Kansas | 913-945-8239 | jholzbeierlein@kumc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Placebo |
| Drug |
Placebo |
|
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Participants |
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Subjects will receive placebo Placebo: Placebo | 0 | 11 | 0 | 11 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |