Clinical trial · Interventional
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
NCT04743934CI-TRIAL-00118651RAD 2003completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy | Drug | — | UNRESOLVED |
| Flibanserin 100 MG | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flibanserin + ADT
- description
- Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
- interventionNames
- Drug: Flibanserin 100 MG
- Drug: Androgen deprivation therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo + ADT
- description
- Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
- interventionNames
- Drug: Placebo
- Drug: Androgen deprivation therapy
Primary outcomes (1)
- measure
- Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Ability to take oral medication and be willing to adhere to the study regimen. * Male age \>18 years. * Histologically confirmed prostate cancer. * Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy. * Serum testosterone \<50 ng/dL. * Serum AST and ALT less than 2 times upper limit of normal. * Endorsed reduced sexual interest. * Attempted intercourse. * Current sexual partner. * Was sexually active with partner within 6 months prior to ADT. * No other antineoplastic therapy planned during study period. * No active symptoms attributable to systemic prostate cancer. Exclusion Criteria: * Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone. * Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors. * Current symptoms attributable to active prostate cancer * Moderate or heavy alcohol use (\>2 drinks/day) * Concurrent moderate or strong CYP3A4 inhibitors * Concurrently taking medication classified as a monoamine oxidase inhibitor.
References
Publications (0)
Data not yet available
No reference posted for this study.