ClinicalTrials.Veeva

Menu

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

Forest Laboratories logo

Forest Laboratories

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo
Drug: Vilazodone 20 mg
Drug: Paroxetine 20 mg
Drug: Vilazodone 40 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02097147
VLZ-MD-24

Details and patient eligibility

About

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

Enrollment

202 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

202 participants in 4 patient groups, including a placebo group

Vilazodone 20 mg
Experimental group
Description:
Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 28 days.
Treatment:
Drug: Vilazodone 20 mg
Vilazodone 40 mg
Experimental group
Description:
Vilazodone 10 mg once daily for 7 days, followed by vilazodone 20 mg once daily for 7 days, followed by vilazodone 40 mg once daily for 21 days
Treatment:
Drug: Vilazodone 40 mg
Paroxetine 20 mg
Active Comparator group
Description:
Paroxetine 10 mg once daily for 7 days, followed by paroxetine 20 mg for 28 days
Treatment:
Drug: Paroxetine 20 mg
Placebo
Placebo Comparator group
Description:
Placebo once daily for 35 days
Treatment:
Drug: Placebo

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems