Trial Outcomes & Findings for A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder (NCT NCT01103362)

Last Updated: 2014-05-12

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

596 participants

Primary outcome timeframe

A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Results posted on

2014-05-12

Participant milestones
Measure	Flibanserin 100mg flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
Overall Study STARTED	596
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	596

Reasons for withdrawal
Measure	Flibanserin 100mg flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
Overall Study study terminated	596

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

Baseline characteristics by cohort
Measure	Flibanserin 100mg n=596 Participants flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
Age, Customized age	45.7 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	596 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	473 participants n=5 Participants
Race/Ethnicity, Customized White Hispanic	53 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	53 participants n=5 Participants
Race/Ethnicity, Customized Black/African American Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	7 participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	7 participants n=5 Participants
Race/Ethnicity, Customized Hawaiian/Pacific Islander	2 participants n=5 Participants

Timeframe: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Outcome measures
Measure	Flibanserin 100mg n=596 Participants flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
The Frequency of Adverse Events	59.2 percentage of patients-any adverse event

Serious events: 4 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events
Measure	Flibanserin 100mg n=596 participants at risk flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
Infections and infestations Cellulitis	0.17% 1/596 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.17% 1/596 • Number of events 1
Gastrointestinal disorders Irritable Bowel Syndrome	0.17% 1/596 • Number of events 1
Injury, poisoning and procedural complications Animal Bite	0.17% 1/596 • Number of events 1

Other adverse events
Measure	Flibanserin 100mg n=596 participants at risk flibanserin 100mg po qd flibanserin: all patients will receive open-label flibanserin 100mg
Nervous system disorders Dizziness	9.6% 57/596 • Number of events 63
Nervous system disorders somnolence	7.9% 47/596 • Number of events 49
Psychiatric disorders Insomnia	5.7% 34/596 • Number of events 34
Gastrointestinal disorders Nausea	5.4% 32/596 • Number of events 35

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