Trial Outcomes & Findings for Effects of Flibanserin on the Pre- and Post-menopausal Female Brain (NCT NCT02770768)

Results Overview

Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-05-16

Participant Flow

No participants started the trial and received the intervention.

Participant milestones

Participant milestones
Measure	Flibanserin Drug: Flibanserin * 8 weeks * 100mg once daily at bedtime Flibanserin: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.	Placebo Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime) Placebo: Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching 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

Effects of Flibanserin on the Pre- and Post-menopausal Female Brain

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 8 weeks

Population: No data was collected or analyzed

Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: No data was collected or analyzed

Change from baseline eye movement tracking results at 8 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Flibanserin

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

Compliance Specialist

University of Chicago

Phone: 773-702-6505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place