Trial Outcomes & Findings for Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) (NCT NCT01188603)

Results Overview

Geometric mean of the AUC\_0-∞ of Flibanserin

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

8 days

Results posted on

2014-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Flibanserin 100mg Flibanserin administered orally once daily
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flibanserin n=24 Participants 100mg Flibanserin administered orally once daily
Age, Continuous	59.6 Years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
BMI	28.25 kg/m^2 STANDARD_DEVIATION 5.31 • n=5 Participants

PRIMARY outcome

Timeframe: 8 days

Geometric mean of the AUC\_0-∞ of Flibanserin

Outcome measures

Outcome measures
Measure	Flibanserin n=22 Participants 100mg Flibanserin administered orally once daily
Flibanserin: Area Under the Curve; AUC_0-∞	2570 ng*h/mL Geometric Coefficient of Variation 73.0

PRIMARY outcome

Timeframe: 8 days

Population: All patients with values for the area under the concentration-time curve of the analyte in plasma over a dosing interval τ at steady state (AUC τ,ss)

Geometric mean of the AUC τ,ss of Flibanserin

Outcome measures

Outcome measures
Measure	Flibanserin n=24 Participants 100mg Flibanserin administered orally once daily
Flibanserin: AUC τ,ss	3000 ng*h/mL Geometric Coefficient of Variation 60.9

PRIMARY outcome

Timeframe: 8 days

Population: All patients with values for the maximum concentration of Flibanserin in plasma after single dose (Cmax)

Geometric mean of the Cmax of Flibanserin

Outcome measures

Outcome measures
Measure	Flibanserin n=22 Participants 100mg Flibanserin administered orally once daily
Flibanserin: Cmax (Peak Concentration)	298 ng/mL Geometric Coefficient of Variation 56.4

PRIMARY outcome

Timeframe: 8 days

Population: All patients with values for the maximum concentration of Flibanserin in plasma after single dose at steady state (Cmax,ss)

Geometric mean of the Cmax,ss of Flibanserin

Outcome measures

Outcome measures
Measure	Flibanserin n=24 Participants 100mg Flibanserin administered orally once daily
Flibanserin: Cmax,ss	406 ng/mL Geometric Coefficient of Variation 60.7

PRIMARY outcome

Timeframe: 8 days

Population: All patients with values for the time from dosing to the maximum measured concentration of flibanserin in plasma after single dose at steady state (tmax,ss)

Median of the tmax,ss of Flibanserin

Outcome measures

Outcome measures
Measure	Flibanserin n=24 Participants 100mg Flibanserin administered orally once daily
Flibanserin: Tmax,ss	1.50 h Full Range 0.500;3.00 • Interval 0.5 to 3.0

Adverse Events

Flibanserin

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flibanserin n=24 participants at risk 100mg Flibanserin administered orally once daily
Gastrointestinal disorders Constipation	8.3% 2/24
Gastrointestinal disorders Dry mouth	12.5% 3/24
Gastrointestinal disorders Dyspepsia	12.5% 3/24
Gastrointestinal disorders Nausea	16.7% 4/24
Gastrointestinal disorders Vomiting	12.5% 3/24
Nervous system disorders Dizziness	25.0% 6/24
Nervous system disorders Headache	8.3% 2/24
Nervous system disorders Somnolence	20.8% 5/24
Psychiatric disorders Insomnia	8.3% 2/24

Additional Information

Sprout Pharmaceuticals

Phone: 1-919-882-0850

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Sprout Pharmaceuticals publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER