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Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers

NCT02932904 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2018-09-14

Study results available
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Summary

The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants after 5 weeks of double-blind treatment.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Vortioxetine

Vortioxetine Overencapsulated Tablet

DRUG

Paroxetine

Paroxetine Overencapsulated Tablets.

DRUG

Placebo

Vortioxetine Placebo-matching Capsules.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-21
Primary Completion
2017-05-31
Completion
2017-06-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932904 on ClinicalTrials.gov