Trial Outcomes & Findings for Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers (NCT NCT02932904)

Last Updated: 2018-09-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

361 participants

Primary outcome timeframe

Baseline and Week 5

Results posted on

2018-09-14

Participant Flow

Participants took part in the study at 16 investigative sites in the United States from 21 November 2016 to 09 June 2017.

Healthy volunteers were randomized in a 1:1:1:1 ratio to one of 4 treatment arms: vortioxetine 10 mg, vortioxetine 20 mg, paroxetine or placebo.

Participant milestones

Participant milestones
Measure	Placebo Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.	Paroxetine 20 mg Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg 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.
Overall Study STARTED	92	85	91	93
Overall Study Treated	91	84	91	91
Overall Study COMPLETED	76	67	68	79
Overall Study NOT COMPLETED	16	18	23	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.	Paroxetine 20 mg Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg 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.
Overall Study Reason not Specified	1	0	2	2
Overall Study Noncompliance with Study Drug	2	3	3	4
Overall Study Pregnancy	0	1	1	0
Overall Study Study Termination	0	1	0	0
Overall Study Voluntary Withdrawal	2	1	4	2
Overall Study Lost to Follow-up	5	3	6	0
Overall Study Significant Protocol Deviation	2	3	6	1
Overall Study Pretreatment Event/Adverse Event	3	5	1	3
Overall Study Randomized But Not Treated	1	1	0	2

Baseline Characteristics

All randomized participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=92 Participants Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.	Paroxetine 20 mg n=85 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=91 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=93 Participants 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.	Total n=361 Participants Total of all reporting groups
Age, Continuous	27.8 years STANDARD_DEVIATION 5.45 • n=92 Participants • All randomized participants.	28.9 years STANDARD_DEVIATION 5.96 • n=85 Participants • All randomized participants.	28.1 years STANDARD_DEVIATION 5.56 • n=91 Participants • All randomized participants.	28.8 years STANDARD_DEVIATION 5.91 • n=93 Participants • All randomized participants.	28.4 years STANDARD_DEVIATION 5.72 • n=361 Participants • All randomized participants.
Sex: Female, Male Female	46 Participants n=92 Participants • All randomized participants.	42 Participants n=85 Participants • All randomized participants.	44 Participants n=91 Participants • All randomized participants.	44 Participants n=93 Participants • All randomized participants.	176 Participants n=361 Participants • All randomized participants.
Sex: Female, Male Male	46 Participants n=92 Participants • All randomized participants.	43 Participants n=85 Participants • All randomized participants.	47 Participants n=91 Participants • All randomized participants.	49 Participants n=93 Participants • All randomized participants.	185 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Hispanic or Latino	21 Participants n=92 Participants • All randomized participants.	20 Participants n=85 Participants • All randomized participants.	25 Participants n=91 Participants • All randomized participants.	18 Participants n=93 Participants • All randomized participants.	84 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Non-Hispanic and Latino	71 Participants n=92 Participants • All randomized participants.	65 Participants n=85 Participants • All randomized participants.	66 Participants n=91 Participants • All randomized participants.	75 Participants n=93 Participants • All randomized participants.	277 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=92 Participants • All randomized participants.	0 Participants n=85 Participants • All randomized participants.	3 Participants n=91 Participants • All randomized participants.	0 Participants n=93 Participants • All randomized participants.	3 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Asian	7 Participants n=92 Participants • All randomized participants.	3 Participants n=85 Participants • All randomized participants.	2 Participants n=91 Participants • All randomized participants.	3 Participants n=93 Participants • All randomized participants.	15 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Black or African American	30 Participants n=92 Participants • All randomized participants.	29 Participants n=85 Participants • All randomized participants.	31 Participants n=91 Participants • All randomized participants.	34 Participants n=93 Participants • All randomized participants.	124 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=92 Participants • All randomized participants.	1 Participants n=85 Participants • All randomized participants.	0 Participants n=91 Participants • All randomized participants.	0 Participants n=93 Participants • All randomized participants.	1 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized White	51 Participants n=92 Participants • All randomized participants.	49 Participants n=85 Participants • All randomized participants.	52 Participants n=91 Participants • All randomized participants.	55 Participants n=93 Participants • All randomized participants.	207 Participants n=361 Participants • All randomized participants.
Race/Ethnicity, Customized Multiracial	4 Participants n=92 Participants • All randomized participants.	3 Participants n=85 Participants • All randomized participants.	3 Participants n=91 Participants • All randomized participants.	1 Participants n=93 Participants • All randomized participants.	11 Participants n=361 Participants • All randomized participants.
Region of Enrollment United States	92 Participants n=92 Participants • All randomized participants.	85 Participants n=85 Participants • All randomized participants.	91 Participants n=91 Participants • All randomized participants.	93 Participants n=93 Participants • All randomized participants.	361 Participants n=361 Participants • All randomized participants.
Median Age Categories ≤ 28 Years	51 Participants n=92 Participants • All randomized participants.	43 Participants n=85 Participants • All randomized participants.	52 Participants n=91 Participants • All randomized participants.	47 Participants n=93 Participants • All randomized participants.	193 Participants n=361 Participants • All randomized participants.
Median Age Categories > 28 Years	41 Participants n=92 Participants • All randomized participants.	42 Participants n=85 Participants • All randomized participants.	39 Participants n=91 Participants • All randomized participants.	46 Participants n=93 Participants • All randomized participants.	168 Participants n=361 Participants • All randomized participants.
Race Categories White	51 Participants n=92 Participants • All randomized participants.	49 Participants n=85 Participants • All randomized participants.	52 Participants n=91 Participants • All randomized participants.	55 Participants n=93 Participants • All randomized participants.	207 Participants n=361 Participants • All randomized participants.
Race Categories Non-white	41 Participants n=92 Participants • All randomized participants.	36 Participants n=85 Participants • All randomized participants.	39 Participants n=91 Participants • All randomized participants.	38 Participants n=93 Participants • All randomized participants.	154 Participants n=361 Participants • All randomized participants.
Height	172.0 cm STANDARD_DEVIATION 10.75 • n=92 Participants • All randomized participants.	172.1 cm STANDARD_DEVIATION 10.59 • n=85 Participants • All randomized participants.	171.3 cm STANDARD_DEVIATION 9.14 • n=91 Participants • All randomized participants.	170.8 cm STANDARD_DEVIATION 10.04 • n=93 Participants • All randomized participants.	171.5 cm STANDARD_DEVIATION 10.12 • n=361 Participants • All randomized participants.
Weight	76.49 kg STANDARD_DEVIATION 15.523 • n=92 Participants • All randomized participants.	80.19 kg STANDARD_DEVIATION 16.808 • n=85 Participants • All randomized participants.	78.67 kg STANDARD_DEVIATION 14.850 • n=91 Participants • All randomized participants.	75.12 kg STANDARD_DEVIATION 13.282 • n=93 Participants • All randomized participants.	77.56 kg STANDARD_DEVIATION 15.192 • n=361 Participants • All randomized participants.
Body Mass Index (BMI)	25.72 kg/m^2 STANDARD_DEVIATION 3.925 • n=92 Participants • All randomized participants.	26.91 kg/m^2 STANDARD_DEVIATION 4.245 • n=85 Participants • All randomized participants.	26.77 kg/m^2 STANDARD_DEVIATION 4.306 • n=91 Participants • All randomized participants.	25.70 kg/m^2 STANDARD_DEVIATION 3.668 • n=93 Participants • All randomized participants.	26.26 kg/m^2 STANDARD_DEVIATION 4.062 • n=361 Participants • All randomized participants.
Smoking Classification Participant has never smoked	73 Participants n=92 Participants • All randomized participants.	70 Participants n=85 Participants • All randomized participants.	70 Participants n=91 Participants • All randomized participants.	77 Participants n=93 Participants • All randomized participants.	290 Participants n=361 Participants • All randomized participants.
Smoking Classification Participant is a current smoker	7 Participants n=92 Participants • All randomized participants.	2 Participants n=85 Participants • All randomized participants.	4 Participants n=91 Participants • All randomized participants.	7 Participants n=93 Participants • All randomized participants.	20 Participants n=361 Participants • All randomized participants.
Smoking Classification Participant is an ex-smoker	12 Participants n=92 Participants • All randomized participants.	13 Participants n=85 Participants • All randomized participants.	17 Participants n=91 Participants • All randomized participants.	9 Participants n=93 Participants • All randomized participants.	51 Participants n=361 Participants • All randomized participants.
Female Reproductive Status Surgically sterile	3 Participants n=92 Participants • All randomized participants.	4 Participants n=85 Participants • All randomized participants.	2 Participants n=91 Participants • All randomized participants.	3 Participants n=93 Participants • All randomized participants.	12 Participants n=361 Participants • All randomized participants.
Female Reproductive Status Female of childbearing potential	43 Participants n=92 Participants • All randomized participants.	38 Participants n=85 Participants • All randomized participants.	42 Participants n=91 Participants • All randomized participants.	41 Participants n=93 Participants • All randomized participants.	164 Participants n=361 Participants • All randomized participants.
Female Reproductive Status NA/Participant is male	46 Participants n=92 Participants • All randomized participants.	43 Participants n=85 Participants • All randomized participants.	47 Participants n=91 Participants • All randomized participants.	49 Participants n=93 Participants • All randomized participants.	185 Participants n=361 Participants • All randomized participants.
Duration of Menstruation	4.9 days STANDARD_DEVIATION 1.36 • n=45 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	4.4 days STANDARD_DEVIATION 1.27 • n=42 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	4.2 days STANDARD_DEVIATION 1.27 • n=44 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	4.6 days STANDARD_DEVIATION 1.37 • n=43 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	4.5 days STANDARD_DEVIATION 1.33 • n=174 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.
Duration of Menstrual Cycle	28.9 days STANDARD_DEVIATION 5.35 • n=45 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	28.3 days STANDARD_DEVIATION 2.56 • n=42 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	28.2 days STANDARD_DEVIATION 7.07 • n=44 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	28.0 days STANDARD_DEVIATION 6.94 • n=43 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.	28.4 days STANDARD_DEVIATION 5.75 • n=174 Participants • All randomized participants. Here, n=number analysed is the female participants who were evaluable for this parameter at baseline.

PRIMARY outcome

Timeframe: Baseline and Week 5

Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=83 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=85 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=91 Participants 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.	Vortioxetine 20 mg 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.
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) Baseline	59.27 score on a scale Standard Error 0.584	58.56 score on a scale Standard Error 0.578	59.43 score on a scale Standard Error 0.560	—
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) Change from Baseline at Week 5	-3.56 score on a scale Standard Error 0.758	-0.82 score on a scale Standard Error 0.752	-2.51 score on a scale Standard Error 0.727	—

PRIMARY outcome

Timeframe: Baseline and Week 5

Population: mFAS1 included all participants in the FAS except those who had active drug concentrations below the limit of quantification (BLOQ) at all study visits where pharmacokinetic (PK) samples were collected.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=74 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=82 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=84 Participants 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.	Vortioxetine 20 mg 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.
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) Change from Baseline at Week 5	-4.01 score on a scale Standard Error 0.803	-0.63 score on a scale Standard Error 0.763	-2.38 score on a scale Standard Error 0.754	—
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1) Baseline	59.13 score on a scale Standard Error 0.614	58.55 score on a scale Standard Error 0.582	59.36 score on a scale Standard Error 0.576	—

PRIMARY outcome

Timeframe: Baseline and Week 5

Population: mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=60 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=79 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=79 Participants 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.	Vortioxetine 20 mg 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.
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) Baseline	58.73 score on a scale Standard Error 0.675	58.53 score on a scale Standard Error 0.589	59.23 score on a scale Standard Error 0.591	—
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2) Change from Baseline at Week 5	-4.78 score on a scale Standard Error 0.828	-0.47 score on a scale Standard Error 0.724	-1.72 score on a scale Standard Error 0.724	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 3 and 4

Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=83 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=85 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=91 Participants 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.	Vortioxetine 20 mg 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.
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 Week 1	-1.67 score on a scale Standard Error 0.457	-0.54 score on a scale Standard Error 0.453	-0.38 score on a scale Standard Error 0.436	—
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 Week 4	-3.11 score on a scale Standard Error 0.688	-1.20 score on a scale Standard Error 0.683	-2.43 score on a scale Standard Error 0.659	—
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 Week 2	-2.40 score on a scale Standard Error 0.617	-1.18 score on a scale Standard Error 0.612	-1.55 score on a scale Standard Error 0.592	—
Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4 Week 3	-2.77 score on a scale Standard Error 0.661	-0.77 score on a scale Standard Error 0.655	-2.36 score on a scale Standard Error 0.633	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=89 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=83 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg 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.	Vortioxetine 20 mg 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.
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 2	-1.11 score on a scale Standard Error 0.598	-2.40 score on a scale Standard Error 0.617	—	—
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 1	-0.05 score on a scale Standard Error 0.440	-1.67 score on a scale Standard Error 0.457	—	—
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 3	-0.91 score on a scale Standard Error 0.639	-2.77 score on a scale Standard Error 0.661	—	—
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 4	-0.62 score on a scale Standard Error 0.666	-3.11 score on a scale Standard Error 0.688	—	—
Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 5	-0.79 score on a scale Standard Error 0.734	-3.56 score on a scale Standard Error 0.758	—	—

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=89 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=85 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=91 Participants 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.	Vortioxetine 20 mg 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.
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 5	-0.79 score on a scale Standard Error 0.734	-0.82 score on a scale Standard Error 0.752	-2.51 score on a scale Standard Error 0.727	—
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 1	-0.05 score on a scale Standard Error 0.440	-0.54 score on a scale Standard Error 0.453	-0.38 score on a scale Standard Error 0.436	—
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 2	-1.11 score on a scale Standard Error 0.598	-1.18 score on a scale Standard Error 0.612	-1.55 score on a scale Standard Error 0.592	—
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 3	-0.91 score on a scale Standard Error 0.639	-0.77 score on a scale Standard Error 0.655	-2.36 score on a scale Standard Error 0.633	—
Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5 Week 4	-0.62 score on a scale Standard Error 0.666	-1.20 score on a scale Standard Error 0.683	-2.43 score on a scale Standard Error 0.659	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4 and 5

Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.

Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=89 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=83 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=85 Participants 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.	Vortioxetine 20 mg n=91 Participants 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.
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 Week 1	2.2 percentage of participants	2.4 percentage of participants	1.2 percentage of participants	1.1 percentage of participants
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 Week 4	4.5 percentage of participants	9.6 percentage of participants	4.7 percentage of participants	7.7 percentage of participants
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 Week 2	7.9 percentage of participants	8.4 percentage of participants	3.5 percentage of participants	2.2 percentage of participants
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 Week 3	4.5 percentage of participants	8.4 percentage of participants	3.5 percentage of participants	6.6 percentage of participants
Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5 Week 5	3.4 percentage of participants	9.6 percentage of participants	5.9 percentage of participants	9.9 percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.

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 on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=89 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=83 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=85 Participants 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.	Vortioxetine 20 mg n=91 Participants 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.
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Pleasure Score: Week 3	-0.23 score on a scale Standard Error 0.085	-0.44 score on a scale Standard Error 0.088	-0.18 score on a scale Standard Error 0.087	-0.42 score on a scale Standard Error 0.084
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Frequency Score: Week 1	-0.03 score on a scale Standard Error 0.097	-0.35 score on a scale Standard Error 0.100	-0.07 score on a scale Standard Error 0.099	-0.23 score on a scale Standard Error 0.096
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Frequency Score: Week 4	-0.25 score on a scale Standard Error 0.126	-0.55 score on a scale Standard Error 0.130	-0.20 score on a scale Standard Error 0.129	-0.43 score on a scale Standard Error 0.125
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Frequency Score: Week 5	-0.28 score on a scale Standard Error 0.141	-0.66 score on a scale Standard Error 0.145	-0.15 score on a scale Standard Error 0.144	-0.49 score on a scale Standard Error 0.139
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Interest Score: Week 1	0.12 score on a scale Standard Error 0.162	-0.15 score on a scale Standard Error 0.169	-0.16 score on a scale Standard Error 0.167	0.09 score on a scale Standard Error 0.161
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Interest Score: Week 4	-0.11 score on a scale Standard Error 0.200	-0.52 score on a scale Standard Error 0.206	-0.18 score on a scale Standard Error 0.204	-0.35 score on a scale Standard Error 0.198
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Interest Score: Week 5	-0.14 score on a scale Standard Error 0.215	-0.73 score on a scale Standard Error 0.223	-0.05 score on a scale Standard Error 0.221	-0.33 score on a scale Standard Error 0.213
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Arousal/Excitement/Erection Score: Week 2	-0.34 score on a scale Standard Error 0.175	-0.47 score on a scale Standard Error 0.181	-0.35 score on a scale Standard Error 0.179	-0.30 score on a scale Standard Error 0.174
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Arousal/Excitement/Erection Score: Week 4	-0.11 score on a scale Standard Error 0.181	-0.54 score on a scale Standard Error 0.187	-0.10 score on a scale Standard Error 0.185	-0.54 score on a scale Standard Error 0.179
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Arousal/Excitement/Erection Score: Week 5	-0.19 score on a scale Standard Error 0.195	-0.67 score on a scale Standard Error 0.202	-0.03 score on a scale Standard Error 0.200	-0.54 score on a scale Standard Error 0.193
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Orgasm/Completion/Ejaculation Score: Week 2	-0.21 score on a scale Standard Error 0.158	-0.61 score on a scale Standard Error 0.164	-0.26 score on a scale Standard Error 0.162	-0.37 score on a scale Standard Error 0.157
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Orgasm/Completion/Ejaculation Score: Week 5	-0.12 score on a scale Standard Error 0.206	-1.09 score on a scale Standard Error 0.214	-0.42 score on a scale Standard Error 0.211	-0.79 score on a scale Standard Error 0.204
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Frequency Score: Week 3	-0.33 score on a scale Standard Error 0.128	-0.62 score on a scale Standard Error 0.132	-0.23 score on a scale Standard Error 0.131	-0.50 score on a scale Standard Error 0.127
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Interest Score: Week 2	-0.09 score on a scale Standard Error 0.181	-0.38 score on a scale Standard Error 0.186	-0.11 score on a scale Standard Error 0.185	-0.22 score on a scale Standard Error 0.179
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Interest Score: Week 3	-0.16 score on a scale Standard Error 0.193	-0.47 score on a scale Standard Error 0.200	-0.01 score on a scale Standard Error 0.198	-0.28 score on a scale Standard Error 0.191
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Arousal/Excitement/Erection Score: Week 1	-0.01 score on a scale Standard Error 0.136	-0.30 score on a scale Standard Error 0.141	-0.05 score on a scale Standard Error 0.140	-0.03 score on a scale Standard Error 0.135
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Arousal/Excitement/Erection Score: Week 3	-0.22 score on a scale Standard Error 0.182	-0.43 score on a scale Standard Error 0.188	-0.08 score on a scale Standard Error 0.186	-0.51 score on a scale Standard Error 0.180
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Orgasm/Completion/Ejaculation Score: Week 1	-0.12 score on a scale Standard Error 0.130	-0.48 score on a scale Standard Error 0.135	-0.22 score on a scale Standard Error 0.134	-0.15 score on a scale Standard Error 0.129
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Orgasm/Completion/Ejaculation Score: Week 3	-0.20 score on a scale Standard Error 0.176	-0.75 score on a scale Standard Error 0.183	-0.33 score on a scale Standard Error 0.180	-0.67 score on a scale Standard Error 0.175
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Orgasm/Completion/Ejaculation Score: Week 4	-0.14 score on a scale Standard Error 0.194	-1.04 score on a scale Standard Error 0.201	-0.45 score on a scale Standard Error 0.199	-0.72 score on a scale Standard Error 0.192
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Pleasure Score: Week 1	-0.07 score on a scale Standard Error 0.064	-0.36 score on a scale Standard Error 0.066	-0.13 score on a scale Standard Error 0.065	-0.15 score on a scale Standard Error 0.063
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Pleasure Score: Week 2	-0.26 score on a scale Standard Error 0.079	-0.38 score on a scale Standard Error 0.082	-0.25 score on a scale Standard Error 0.081	-0.26 score on a scale Standard Error 0.078
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Pleasure Score: Week 4	-0.18 score on a scale Standard Error 0.085	-0.38 score on a scale Standard Error 0.088	-0.31 score on a scale Standard Error 0.087	-0.37 score on a scale Standard Error 0.084
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Desire/Frequency Score: Week 2	-0.30 score on a scale Standard Error 0.118	-0.46 score on a scale Standard Error 0.122	-0.25 score on a scale Standard Error 0.120	-0.46 score on a scale Standard Error 0.116
Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5 Pleasure Score: Week 5	-0.21 score on a scale Standard Error 0.086	-0.47 score on a scale Standard Error 0.089	-0.16 score on a scale Standard Error 0.088	-0.33 score on a scale Standard Error 0.085

SECONDARY outcome

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

Population: FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.

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 on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.

Outcome measures

Outcome measures
Measure	Paroxetine 20 mg n=89 Participants Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=83 Participants Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=85 Participants 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.	Vortioxetine 20 mg n=91 Participants 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.
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 Desire Score: Week 1	0.09 score on a scale Standard Error 0.225	-0.50 score on a scale Standard Error 0.234	-0.23 score on a scale Standard Error 0.232	-0.14 score on a scale Standard Error 0.223
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 Arousal Score: Week 2	-0.34 score on a scale Standard Error 0.175	-0.47 score on a scale Standard Error 0.181	-0.35 score on a scale Standard Error 0.179	-0.30 score on a scale Standard Error 0.174
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 Desire Score: Week 2	-0.40 score on a scale Standard Error 0.260	-0.83 score on a scale Standard Error 0.269	-0.34 score on a scale Standard Error 0.266	-0.68 score on a scale Standard Error 0.258
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 Desire Score: Week 3	-0.50 score on a scale Standard Error 0.286	-1.09 score on a scale Standard Error 0.296	-0.22 score on a scale Standard Error 0.293	-0.77 score on a scale Standard Error 0.284
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 Desire Score: Week 4	-0.36 score on a scale Standard Error 0.297	-1.07 score on a scale Standard Error 0.307	-0.37 score on a scale Standard Error 0.304	-0.77 score on a scale Standard Error 0.294
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 Desire Score: Week 5	-0.42 score on a scale Standard Error 0.325	-1.38 score on a scale Standard Error 0.336	-0.19 score on a scale Standard Error 0.333	-0.82 score on a scale Standard Error 0.322
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 Arousal Score: Week 1	-0.01 score on a scale Standard Error 0.136	-0.30 score on a scale Standard Error 0.141	-0.05 score on a scale Standard Error 0.140	-0.03 score on a scale Standard Error 0.135
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 Arousal Score: Week 3	-0.22 score on a scale Standard Error 0.182	-0.43 score on a scale Standard Error 0.188	-0.08 score on a scale Standard Error 0.186	-0.51 score on a scale Standard Error 0.180
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 Arousal Score: Week 4	-0.11 score on a scale Standard Error 0.181	-0.54 score on a scale Standard Error 0.187	-0.10 score on a scale Standard Error 0.185	-0.54 score on a scale Standard Error 0.179
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 Arousal Score: Week 5	-0.19 score on a scale Standard Error 0.195	-0.67 score on a scale Standard Error 0.202	-0.03 score on a scale Standard Error 0.200	-0.54 score on a scale Standard Error 0.193
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 Orgasm/Completion/Ejaculation Score: Week 1	-0.12 score on a scale Standard Error 0.130	-0.48 score on a scale Standard Error 0.135	-0.22 score on a scale Standard Error 0.134	-0.15 score on a scale Standard Error 0.129
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 Orgasm/Completion/Ejaculation Score: Week 2	-0.21 score on a scale Standard Error 0.158	-0.61 score on a scale Standard Error 0.164	-0.26 score on a scale Standard Error 0.162	-0.37 score on a scale Standard Error 0.157
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 Orgasm/Completion/Ejaculation Score: Week 3	-0.20 score on a scale Standard Error 0.176	-0.75 score on a scale Standard Error 0.183	-0.33 score on a scale Standard Error 0.180	-0.67 score on a scale Standard Error 0.175
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 Orgasm/Completion/Ejaculation Score: Week 4	-0.14 score on a scale Standard Error 0.194	-1.04 score on a scale Standard Error 0.201	-0.45 score on a scale Standard Error 0.199	-0.72 score on a scale Standard Error 0.192
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 Orgasm/Completion/Ejaculation Score: Week 5	-0.12 score on a scale Standard Error 0.206	-1.09 score on a scale Standard Error 0.214	-0.42 score on a scale Standard Error 0.211	-0.79 score on a scale Standard Error 0.204

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Paroxetine 20 mg

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Vortioxetine 10 mg

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Vortioxetine 20 mg

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=91 participants at risk Vortioxetine placebo matching-capsules, orally, once daily for up to 5 weeks.	Paroxetine 20 mg n=84 participants at risk Paroxetine 20 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 10 mg n=91 participants at risk Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.	Vortioxetine 20 mg n=91 participants at risk 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.
Gastrointestinal disorders Nausea	4.4% 4/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	26.2% 22/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	28.6% 26/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	19.8% 18/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Diarrhoea	3.3% 3/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.0% 5/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Fatigue	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.0% 5/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Upper respiratory tract infection	5.5% 5/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.6% 3/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Viral upper respiratory tract infection	5.5% 5/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.8% 4/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Metabolism and nutrition disorders Decreased appetite	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 6/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	4.4% 4/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Somnolence	4.4% 4/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.9% 10/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 7/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 7/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	6.6% 6/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 6/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.6% 6/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Dizziness	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 6/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Libido decreased	12.1% 11/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	21.4% 18/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	15.4% 14/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	11.0% 10/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Orgasm abnormal	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	16.7% 14/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 7/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Anxiety	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 6/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Psychiatric disorders Insomnia	0.00% 0/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.1% 6/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.1% 1/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Reproductive system and breast disorders Ejaculation delayed	0.00% 0/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.0% 5/84 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.2% 2/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	3.3% 3/91 • From the first dose of study drug on Day 1 until the Follow-up Contact at Week 7 At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER