Trial Outcomes & Findings for SSRI Effects on Semen Parameters in Men (NCT NCT00385762)

NCT ID: NCT00385762

Last Updated: 2017-08-02

Results Overview

measured in mL

• Recruitment status: COMPLETED
• Target enrollment: 35 participants
• Primary outcome timeframe: 2 months post initial visit
• Results posted on: 2017-08-02

Participant Flow

Participant milestones

Measure	Paroxetine Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Paroxetine Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

SSRI Effects on Semen Parameters in Men

Baseline characteristics by cohort

Measure	Paroxetine n=35 Participants Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months post initial visit

measured in mL

Outcome measures

Measure	Paroxetine n=33 Participants Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Semen Volume	2.55 mL Standard Deviation 1.26

PRIMARY outcome

Timeframe: 2 months post initial visit

number of sperm per cubic centimeter of semen

Outcome measures

Measure	Paroxetine n=33 Participants Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Sperm Concentration	75 number of sperm per cubic centimeter Standard Deviation 67.65

PRIMARY outcome

Timeframe: 2 months post initial visit

percent of sperm with movement

Outcome measures

Measure	Paroxetine n=33 Participants Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Sperm Motility	50.21 Percent of sperm with movement Standard Deviation 16.55

PRIMARY outcome

Timeframe: 2 months post initial visit

percent of sperm with normal shape

Outcome measures

Measure	Paroxetine n=33 Participants Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
Sperm Morphology	20.24 percent of sperm with normal shape Standard Deviation 8.89

Adverse Events

Paroxetine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Paroxetine n=33 participants at risk Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.
General disorders Side effect to medication	3.0% 1/33 • Number of events 1

Additional Information

Peter N Schlegel, MD

Weill Cornell Medical College

Phone: 2127465491

Email: pnschleg@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place