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

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02932904

Run by

Takeda

People needed

361

Starts

2016-11-21

Expected to finish

2017-06-09

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
• Has a body mass index (BMI) of 18 to 35 kg/m\^2, inclusive, at the Screening and Baseline Visits.
• If female, has a regular menstrual cycle.
• Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
• If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

You may not qualify if…

• Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
• Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
• Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
• Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
• Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
• Has a history of depression or any other psychiatric illness.
• Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
• Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
• Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
• If female, has polycystic ovarian syndrome.
• Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
• Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.

Where it is running

• Study site — Encino, California, United States
• Study site — Long Beach, California, United States
• Study site — Torrance, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Portland, Oregon, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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