Phase 4
N=361
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02932904 ↗Enrolled (actual)
361
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: 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) — 59.27; 58.56; 59.43; -3.56 score on a scale — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vortioxetine (Drug); Paroxetine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
59.27; 58.56; 59.43; -3.56; -0.82; -2.51 | 0.009 sig |
| PRIMARY Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) |
59.13; 58.55; 59.36; -4.01; -0.63; -2.38 | 0.002 sig |
| PRIMARY Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) |
58.73; 58.53; 59.23; -4.78; -0.47; -1.72 | <0.001 sig |
| SECONDARY Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 |
-1.67; -0.54; -0.38; -2.40; -1.18; -1.55 | 0.072 |
| SECONDARY Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 |
-0.05; -1.67; -1.11; -2.40; -0.91; -2.77 | 0.009 sig |
| SECONDARY Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 |
-0.05; -0.54; -0.38; -1.11; -1.18; -1.55 | 0.419 |
| SECONDARY Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 |
2.2; 2.4; 1.2; 1.1; 7.9; 8.4 | 0.515 |
| SECONDARY Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 |
-0.07; -0.36; -0.13; -0.15; -0.26; -0.38 | — |
| SECONDARY 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 |
0.09; -0.50; -0.23; -0.14; -0.40; -0.83 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02932904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.