Clinical trial · Interventional
Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
NCT00594620CI-TRIAL-00056498terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to poor accrual and without sufficient patients or data to report on any outcomes.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flav-ein capsules | Dietary Supplement | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Subjects receive supplement
- interventionNames
- Dietary Supplement: Flav-ein capsules
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Subjects will receive placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
- timeFrame
- 16 Weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.) * had biochemical/clinical relapse and started on antiandrogens * have documented history of hot flashes Exclusion Criteria: * History of MI, DVT, CVA * peanut allergy * untreated hypothyroidism * must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study
References
Publications (0)
Data not yet available
No reference posted for this study.