Trial Outcomes & Findings for Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (NCT NCT04743934)
NCT ID: NCT04743934
Last Updated: 2026-07-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
Baseline up to 12 weeks
Results posted on
2026-07-20
Participant Flow
Participant milestones
| Measure |
Flibanserin + ADT
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Flibanserin + ADT
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other physician recommendation due to potential drug interactions
|
0
|
1
|
|
Overall Study
Logistics
|
0
|
1
|
Baseline Characteristics
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Flibanserin + ADT
n=23 Participants
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
n=21 Participants
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Age, Continuous
|
67.6 years
n=20 Participants
|
65.4 years
n=20 Participants
|
66.7 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=20 Participants
|
21 participants
n=20 Participants
|
44 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 weeksThe 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.
Outcome measures
| Measure |
Flibanserin + ADT
n=22 Participants
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
n=19 Participants
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: 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
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 weeksDetermined 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.
Outcome measures
| Measure |
Flibanserin + ADT
n=22 Participants
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
n=19 Participants
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
|---|---|---|
|
Sexual Quality of Life (QoL)
|
39.2 T scores
Interval 31.7 to 55.7
|
43.2 T scores
Interval 37.1 to 51.9
|
SECONDARY outcome
Timeframe: Baseline up to 12 weeksToxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.
Outcome measures
| Measure |
Flibanserin + ADT
n=22 Participants
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
n=19 Participants
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
|---|---|---|
|
Frequency of Patient Reported Grade 3+ Adverse Events
|
8 number of events
|
5 number of events
|
Adverse Events
Flibanserin + ADT
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo + ADT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flibanserin + ADT
n=22 participants at risk
Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Flibanserin 100 MG: Flibanserin 100mg tablets taken by mouth daily at bedtime
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
Placebo + ADT
n=19 participants at risk
Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).
Placebo: Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapy: Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
|
|---|---|---|
|
Cardiac disorders
Heart palpitations
|
4.5%
1/22 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
|
General disorders
Fatigue
|
18.2%
4/22 • Number of events 7 • 12 weeks
|
10.5%
2/19 • Number of events 2 • 12 weeks
|
|
Nervous system disorders
Anxiety
|
4.5%
1/22 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
13.6%
3/22 • Number of events 6 • 12 weeks
|
10.5%
2/19 • Number of events 2 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/22 • 12 weeks
|
10.5%
2/19 • Number of events 2 • 12 weeks
|
|
General disorders
Drowsiness
|
4.5%
1/22 • Number of events 1 • 12 weeks
|
0.00%
0/19 • 12 weeks
|
Additional Information
Andrew McDonald, MD
The University of Alabama at Birmingham
Phone: 205-410-3713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place