Trial Outcomes & Findings for Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy (NCT NCT00594620)
NCT ID: NCT00594620
Last Updated: 2022-02-14
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
16 Weeks
Results posted on
2022-02-14
Participant Flow
Study was terminated early due to low accrual. Study was blinded and no data was collected
Participant milestones
| Measure |
Arm 1/ Soy Supplementation
Subjects receive supplement
Flav-ein capsules: Soy/isoflavone supplementation
|
Arm 2/ Placebo
Subjects will receive placebo
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 16 WeeksPopulation: The trial was stopped early due to failure to accrue Not enough subjects were enrolled with enough follow up to have data
Outcome measures
Outcome data not reported
Adverse Events
Flav-ein Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey Holzbeierlein, MD, FACS
The University of Kansas
Phone: 913-945-8239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place