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

NCT02932904 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Vortioxetine-4001U1111-1174-1779
• Study Type: interventional
• Target: 361
• Locations: 1 country
• Sites: 15

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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• 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)

  The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.

  Baseline and Week 5

• Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)

  The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.

  Baseline and Week 5

• Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)

  The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.

  Baseline and Week 5

Secondary Outcomes (6)

• Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4

  Baseline and Weeks 1, 2, 3 and 4

• Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5

  Baseline and Weeks 1, 2, 3, 4 and 5

• Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5

  Baseline and Weeks 1, 2, 3, 4 and 5

• Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5

  Weeks 1, 2, 3, 4 and 5

• Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5

  Baseline and Weeks 1, 2, 3, 4 and 5

Study Arms (4)

Vortioxetine 10 mg

EXPERIMENTAL

Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.

Drug: Vortioxetine

Vortioxetine 20 mg

EXPERIMENTAL

Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.

Drug: Vortioxetine

Paroxetine 20 mg

ACTIVE COMPARATOR

Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.

Drug: Paroxetine

Placebo

PLACEBO COMPARATOR

Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.

Drug: Placebo

Interventions

Vortioxetine DRUG

Vortioxetine Overencapsulated Tablet

Vortioxetine 10 mg; Vortioxetine 20 mg

Paroxetine DRUG

Paroxetine Overencapsulated Tablets.

Paroxetine 20 mg

Placebo DRUG

Vortioxetine Placebo-matching Capsules.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

Unknown Facility

Encino, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Decatur, Georgia, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Las Vegas, Nevada, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

MeSH Terms

Interventions

Vortioxetine; Paroxetine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 13, 2016
• Study Start: November 21, 2016
• Primary Completion: May 31, 2017
• Study Completion: June 9, 2017
• Last Updated: September 14, 2018
• Results First Posted: September 14, 2018

Record last verified: 2018-08

Locations

US (15)