12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

Phase 3

Terminated

• Conditions: Depression; Sexual Dysfunctions, Psychological
• Interventions: Drug: flibanserin 100 mg qhs; Drug: flibanserin 50 mg to 100 mg qhs; Drug: placebo 2 tablets qhs

• Registration Number: NCT01040208
• Lead Sponsor: Sprout Pharmaceuticals, Inc

Brief Summary

The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-29
• Study Start: 2010-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2013-06-06
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-14
• Last Update Submitted: 2016-07-14
• Results First Posted: 2016-08-24
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
flibanserin 100 mg qhs	flibanserin 100 mg qhs	Patient to receive 2 flibanserin tablets of 50 mg qhs
flibanserin 50 mg to 100 mg qhs	flibanserin 50 mg to 100 mg qhs	Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
placebo 2 tablets qhs	placebo 2 tablets qhs	Patient to receive 2 placebo tablets of 50 mg qhs

Primary Outcome Measures

Name	Time	Method
The Primary Safety Endpoint is the Occurrence of Adverse Events During the Treatment and Post Treatment Period.	17 weeks

Secondary Outcome Measures

Name	Time	Method
The Occurrence of Mild Depressive Symptoms (i.e., a Total Score of '7' to '11', Inclusive) That Have Remitted (i.e., a Total Score of '6' or Less) on the 16 Item Quick Inventory of Depressive Symptoms - Self Report at Visit 6 (Week 12)	12 weeks
The Occurrence of Mild Anxiety Symptoms (i.e., a Total Score of '8' to '16', Inclusive) That Have Remitted (i.e., a Total Score of '7' or Less) on the Beck Anxiety Inventory at Visit 6 (Week 12)	12 weeks

Trial Locations

Locations (39)

Clinical Innovations; 🇺🇸 Riverside, California, United States

Mood & Anxiety Research; 🇺🇸 Fresno, California, United States

Synergy Clinical Research Center; 🇺🇸 National City, California, United States

Schuster Medical Research; 🇺🇸 Sherman Oaks, California, United States

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

Western Affiliated Research Institute; 🇺🇸 Denver, Colorado, United States

Radiant Research; 🇺🇸 Denver, Colorado, United States

Ali Kashfi; 🇺🇸 Altamonte Springs, Florida, United States

Gulf Coast Clinical Research; 🇺🇸 Fort Myers, Florida, United States

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

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