Clinical trial NCT02932904: Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Official title: A Randomized, Double-Blind, Parallel Group, Placebo- and Active-Controlled, Phase 4 Study Evaluating the Effect of Vortioxetine 10 and 20 mg/Day vs Paroxetine 20 mg/Day on Sexual Functioning in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The drug being tested in this study is called vortioxetine. This study will look at the effect of treatment on sexual functioning in healthy participants.

The study will enroll approximately 352 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Vortioxetine 10 mg
* Vortioxetine 20 mg
* Paroxetine 20 mg
* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient

All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.

This multicenter trial will be conducted in United States. The overall time to participate in this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
2. Has a body mass index (BMI) of 18 to 35 kg/m\^2, inclusive, at the Screening and Baseline Visits.
3. If female, has a regular menstrual cycle.
4. 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.
5. 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.

Exclusion Criteria:

1. Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
2. 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.
3. Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
4. Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
5. Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
6. Has a history of depression or any other psychiatric illness.
7. Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
8. Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
9. Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
10. If female, has polycystic ovarian syndrome.
11. Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
12. Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.

Primary outcomes:
measure: Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)
timeFrame: Baseline and Week 5
measure: Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)
timeFrame: Baseline and Week 5
measure: Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)
timeFrame: Baseline and Week 5
Secondary outcomes:
measure: Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4
timeFrame: Baseline and Weeks 1, 2, 3 and 4
measure: Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
timeFrame: Baseline and Weeks 1, 2, 3, 4 and 5
measure: Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5
timeFrame: Baseline and Weeks 1, 2, 3, 4 and 5
measure: Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5
timeFrame: Weeks 1, 2, 3, 4 and 5
measure: Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5
timeFrame: Baseline and Weeks 1, 2, 3, 4 and 5
measure: Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5
timeFrame: Baseline and Weeks 1, 2, 3, 4 and 5
Other outcomes:
Locations:
city: Encino
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Torrance
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: