Trial Outcomes & Findings for A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD). (NCT NCT00441558)

Last Updated: 2014-06-13

Results Overview

This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1723 participants

Primary outcome timeframe

52 weeks

Results posted on

2014-06-13

Participant milestones
Measure	Flibanserin Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Overall Study STARTED	1723
Overall Study COMPLETED	667
Overall Study NOT COMPLETED	1056

Withdrawal data not reported

A One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).

Baseline characteristics by cohort
Measure	Flibanserin n=1723 Participants Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Age, Customized 18-29 years	266 participants n=39 Participants
Age, Customized 30-39 years	749 participants n=39 Participants
Age, Customized 40-49 years	672 participants n=39 Participants
Age, Customized 50 years and older	36 participants n=39 Participants
Sex: Female, Male Female	1723 Participants n=39 Participants
Sex: Female, Male Male	0 Participants n=39 Participants
Race/Ethnicity, Customized White	1492 participants n=39 Participants
Race/Ethnicity, Customized White Hispanic	85 participants n=39 Participants
Race/Ethnicity, Customized Black	119 participants n=39 Participants
Race/Ethnicity, Customized Black Hispanic	6 participants n=39 Participants
Race/Ethnicity, Customized Asian	21 participants n=39 Participants

Timeframe: 52 weeks

This is a 52-week, open label trial assessing safety/tolerability of flibanserin in women with Hypoactive Sexual Desire Disorder

Outcome measures
Measure	Flibanserin n=1723 Participants Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
The Frequency of Adverse Events (Side Effects).	1272 participants with any adverse event

Serious events: 15 serious events

Other events: 995 other events

Deaths: 0 deaths

Serious adverse events
Measure	Flibanserin n=1723 participants at risk Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Infections and infestations Abdominal abscess	0.06% 1/1723 • Number of events 1
Infections and infestations Appendicitis	0.12% 2/1723 • Number of events 2
Infections and infestations Pneumonia	0.06% 1/1723 • Number of events 1
Infections and infestations Urinary tract infection	0.06% 1/1723 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melonoma	0.06% 1/1723 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.06% 1/1723 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.06% 1/1723 • Number of events 1
Endocrine disorders Thyroid mass	0.06% 1/1723 • Number of events 1
Nervous system disorders Cervicobrachial syndrome	0.06% 1/1723
Cardiac disorders Atrioventricular block complete	0.06% 1/1723
Cardiac disorders Bradycardia	0.06% 1/1723 • Number of events 1
Cardiac disorders Mitral valve prolapse	0.06% 1/1723 • Number of events 1
Vascular disorders Aortic aneurysm	0.06% 1/1723 • Number of events 1
Vascular disorders Aortic stenosis	0.06% 1/1723 • Number of events 1

Other adverse events
Measure	Flibanserin n=1723 participants at risk Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Nervous system disorders Somnolence	16.0% 275/1723 • Number of events 315
Nervous system disorders Fatigue	7.6% 131/1723 • Number of events 142
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	7.1% 123/1723 • Number of events 139
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	7.2% 124/1723 • Number of events 135
Nervous system disorders Dizziness	7.0% 120/1723 • Number of events 152
Nervous system disorders Headache	6.6% 113/1723 • Number of events 156
Gastrointestinal disorders Nausea	6.3% 109/1723 • Number of events 132

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