A Phase 2 interventional study of Flibanserin 100 MG and Placebo in Prostate Adenocarcinoma, sponsored by Andrew McDonald. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Andrew McDonald · Phase 2, Interventional, and Treatment
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.
More than 40,000 men with prostate cancer in the United States will begin androgen deprivation therapy (ADT) each year. ADT is an important part of treatment, because it improves survival for men with metastatic or high-risk localized disease, and reduces rates of biochemical progression for men with intermediate-risk localized disease who receive radiation. The most common ADT agents modulate gonadotropin-releasing hormone to suppress the downstream testosterone production, resulting in testosterone levels similar to those observed following surgical castration (\<20 ng/dL). Since male sexual interest is highly correlated with serum testosterone levels, loss of sexual interest is nearly universal among men who receive ADT.Sexual dysfunction is the most common complaint among men with prostate cancer and contributes to lower overall quality of life (QoL) experienced by men receiving ADT. Furthermore, the loss of sexual interest experienced during ADT is highly distressing for men with prostate cancer and their partners, which contributes additional psychological morbidity in these patients.
Flibanserin is approved for treatment of female hypoactive sexual desire disorder, and the safety profile of 100mg daily flibanserin is well described in premenopausal women.The safety profile of flibanserin in healthy men has been assessed in multiple phase I clinical trials, but has not been evaluated among men receiving ADT for prostate cancer.
This is a phase II randomized, double-blinded, placebo-controlled clinical trial designed to provide an initial estimate of the efficacy of flibanserin to promote sexual interest in men with prostate cancer receiving androgen suppression therapy and to confirm the safety profile. This study will take place at a single academic comprehensive cancer center.
Following confirmation of eligibility, participants who are enrolled in this study are randomized to receive daily flibanserin 100mg or placebo for a 12-week period.
This is the only study on the registry with Andrew McDonald as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Drug: Flibanserin 100 MG · Drug: Androgen deprivation therapy
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Drug: Placebo · Drug: Androgen deprivation therapy
Flibanserin 100mg tablets taken by mouth daily at bedtime
Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month
The number of patients in each arm reporting attempting sexual intercourse at least 3 times in the prior month (0-2 attempts vs. 3+ attempts) will be compared using the two-group chi-square test, or Fisher's exact test if the assumptions for the chi-square test are not tenable.
Time frame: Baseline up to 12 weeks
Sexual Quality of Life (QoL)
Determined using T-scores from the PROMIS v2.0 Brief Sexual Function and Satisfaction (Male) form and comparing T-score between patients receiving flibanserin and patients receiving placebo. Higher scores indicate better sexual functions. A T-score of 50 represents the population mean with a standard deviation of 10. The difference in 3 to 5 T-score points is generally considered a clinically meaningful change.
Time frame: 12 weeks
Frequency of Patient Reported Grade 3+ Adverse Events
Toxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.
Time frame: Baseline up to 12 weeks
| Milestone | Flibanserin + ADT | Placebo + ADT |
|---|---|---|
| Started | 23 | 21 |
| Completed | 22 | 19 |
| Not completed | 1 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Other physician recommendation due to potential drug interactions | 0 | 1 |
| Withdrew: Logistics | 0 | 1 |
The number of patients in each arm reporting attempting sexual intercourse at least 3 times in the prior month (0-2 attempts vs. 3+ attempts) will be compared using the two-group chi-square test, or Fisher's exact test if the assumptions for the chi-square test are not tenable.
| Participants | Flibanserin + ADT | Placebo + ADT |
|---|---|---|
| Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month | 1 | 3 |
Determined using T-scores from the PROMIS v2.0 Brief Sexual Function and Satisfaction (Male) form and comparing T-score between patients receiving flibanserin and patients receiving placebo. Higher scores indicate better sexual functions. A T-score of 50 represents the population mean with a standard deviation of 10. The difference in 3 to 5 T-score points is generally considered a clinically meaningful change.
| T scores | Flibanserin + ADT | Placebo + ADT |
|---|---|---|
| Sexual Quality of Life (QoL) | 39.2 (31.7 to 55.7) | 43.2 (37.1 to 51.9) |
Toxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.
| number of events | Flibanserin + ADT | Placebo + ADT |
|---|---|---|
| Frequency of Patient Reported Grade 3+ Adverse Events | 8 | 5 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flibanserin + ADT | 0/22 (0%) | 0/22 (0%) | 10/22 (45.5%) |
| Placebo + ADT | 0/19 (0%) | 0/19 (0%) | 6/19 (31.6%) |
| Event | Flibanserin + ADT | Placebo + ADT |
|---|---|---|
| FatigueGeneral disorders | 4/22 | 2/19 |
| Dry mouthGastrointestinal disorders | 3/22 | 2/19 |
| Shortness of BreathRespiratory, thoracic and mediastinal disorders | 0/22 | 2/19 |
| DrowsinessGeneral disorders | 1/22 | 0/19 |
| Heart palpitationsCardiac disorders | 1/22 | 0/19 |
| AnxietyNervous system disorders | 1/22 | 0/19 |
| Age, Categorical(Participants) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 9 | 15 |
| >=65 years | 17 | 12 | 29 |
| Age, Continuous(years) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| Median | 67.6 (52.9 to 76.9) | 65.4 (54.7 to 76.4) | 66.7 (52.9 to 76.9) |
| Sex: Female, Male(Participants) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 23 | 21 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 23 | 21 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 13 | 29 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Flibanserin + ADT | Placebo + ADT | Total |
|---|---|---|---|
| United States | 23 | 21 | 44 |
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