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Study to Evaluate the Sexual Functioning of Healthy Adults After Receiving Vilazodone, Paroxetine or Placebo

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Vilazodone 20 mg (Drug); Vilazodone 40 mg (Drug); Paroxetine 20 mg (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Maju Mathews, MD, Study Director, Affiliation: Forest Laboratories

Summary

To compare the effects of vilazodone, paroxetine and placebo on sexual function in sexually active healthy adults.

Clinical Details

Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study Evaluating The Sexual Functioning of Healthy Adults After Receiving Multiple-Dose Regimens of Vilazodone, Paroxetine, or Placebo

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Change in Changes in Sexual Functioning Questionnaire (CSFQ) total score

Secondary outcome: Proportion of subjects meeting criteria for sexual dysfunction.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female, aged 18 through 45 years, inclusive

- Currently sexually active

- If female, non pregnant and agree to use acceptable for of contraception during

- If male, be sterile or have partner use contraception.

Exclusion Criteria:

- Have sexual dysfunction

- Have history of diagnosis or treatment of any disorder related to sexual functioning.

- Clinically significant disease state, in the opinion of the examining physician, in

any body system

- History of alcohol or other substance abuse or dependence within the previous 5 years

Locations and Contacts

Forest Investigative Site 001, Miami, Florida 33014, United States

Forest Investigative Site 002, Overland Park, Kansas 66212, United States

Forest Investigative Site 003, St. Paul, Minnesota 55114, United States

Forest Investigative Site 004, Charlottesville, Virginia 22903, United States

Additional Information

Starting date: March 2014
Last updated: February 11, 2015

Page last updated: August 23, 2015

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