|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01040208 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexual Dysfunctions, Psychological Depression |
Drug: flibanserin 2 Drug: placebo Drug: flibanserin 1 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Safety of Flibanserin Versus Placebo in Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire |
| Enrollment: | 111 |
| Study Start Date: | January 2010 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: flibanserin 1
50 mg qhs for 14 days then 100mg qhs
|
|
Experimental: flibanserin 100 mg qhs
Patient to receive 2 flibanserin tablets of 50 mg qhs
|
Drug: flibanserin 2
100mg qhs
|
|
Experimental: placebo 2 tablets qhs
Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
|
Drug: placebo
2 tablets qhs
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Clinically relevant conditions which might interfere with the patient's ability to participate in the trial include, but are not limited to the following:
Contacts and Locations
Show 42 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01040208 History of Changes |
| Other Study ID Numbers: | 511.114 |
| Study First Received: | December 28, 2009 |
| Last Updated: | June 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Depression Depressive Disorder Sexual Dysfunctions, Psychological Behavioral Symptoms Mood Disorders Mental Disorders Sexual and Gender Disorders Norepinephrine Serotonin Serotonin Uptake Inhibitors Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Uptake Inhibitors |