Trial Outcomes & Findings for Impact of Duloxetine on Male Fertility (NCT NCT03038867)

Results Overview

Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

6 Weeks (primary time point of interest)

Results posted on

2020-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Overall Study STARTED	37	32
Overall Study COMPLETED	37	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=37 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=32 Participants	0 Participants n=69 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=37 Participants	32 Participants n=32 Participants	69 Participants n=69 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=32 Participants	0 Participants n=69 Participants
Sex: Female, Male Female	0 Participants n=37 Participants	0 Participants n=32 Participants	0 Participants n=69 Participants
Sex: Female, Male Male	37 Participants n=37 Participants	32 Participants n=32 Participants	69 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	37 Participants n=37 Participants	32 Participants n=32 Participants	69 Participants n=69 Participants

PRIMARY outcome

Timeframe: 6 Weeks (primary time point of interest)

Population: 11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).

Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=25 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 0 weeks

Population: 5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)

Number of participants with Tunel Values \> 25% at 0 Weeks (baseline) in each treatment group

Outcome measures

Outcome measures
Measure	Duloxetine n=32 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).

Number of participants with Tunel values \> 25% at 2 weeks in each treatment group

Outcome measures

Outcome measures
Measure	Duloxetine n=25 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).

Number of participants with Tunel values \> 25% at 8 weeks in each treatment group

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 10 Weeks

Population: 18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).

Number of participants with Tunel values \> 25% at 10 weeks in each treatment group

Outcome measures

Outcome measures
Measure	Duloxetine n=19 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).

Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Concentration at 0 Weeks	57.4 Number of sperm/mL Standard Deviation 40.3	50.2 Number of sperm/mL Standard Deviation 33.4

SECONDARY outcome

Timeframe: 2 weeks

Population: 10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).

Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=27 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Concentration at 2 Weeks	48.9 Number of sperm/mL Standard Deviation 38.7	50.0 Number of sperm/mL Standard Deviation 41.4

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).

Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Concentration at 6 Weeks	44.6 Number of sperm/mL Standard Deviation 24.2	43.9 Number of sperm/mL Standard Deviation 32.5

SECONDARY outcome

Timeframe: 8 weeks

Population: 14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).

Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=23 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Concentration at 8 Weeks	45.7 Number of sperm/mL Standard Deviation 29.8	47.1 Number of sperm/mL Standard Deviation 28.7

SECONDARY outcome

Timeframe: 10 Weeks

Population: 16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).

Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=21 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Concentration at 10 Weeks	42.0 Number of sperm/mL Standard Deviation 26.3	42.7 Number of sperm/mL Standard Deviation 26.0

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).

Sperm motility (mean percent) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Motility at 0 Weeks	61.7 percent motility Standard Deviation 9.5	59.7 percent motility Standard Deviation 11.4

SECONDARY outcome

Timeframe: 2 weeks

Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).

Sperm motility (mean percent) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Motility at 2 Weeks	54.3 percent motility Standard Deviation 13.3	55.2 percent motility Standard Deviation 13.4

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).

Sperm motility (mean percent) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Motility at 6 Weeks	57.2 percent motility Standard Deviation 11.2	50.4 percent motility Standard Deviation 20.6

SECONDARY outcome

Timeframe: 8 weeks

Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).

Sperm motility (mean percent) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=24 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Motility at 8 Weeks	51.1 percent motility Standard Deviation 18.6	58.5 percent motility Standard Deviation 12.1

SECONDARY outcome

Timeframe: 10 Weeks

Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).

Sperm motility (mean percent) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=29 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Motility at 10 Weeks	54.4 percent motility Standard Deviation 17.4	53.9 percent motility Standard Deviation 19.7

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).

Sperm head defects (mean number) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Head Defects at 0 Weeks	88.4 defects Standard Deviation 16.0	89.9 defects Standard Deviation 8.11

SECONDARY outcome

Timeframe: 2 weeks

Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).

Sperm head defects (mean number) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Head Defects at 2 Weeks	91.5 defects Standard Deviation 4.02	90.7 defects Standard Deviation 7.86

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).

Sperm head defects (mean number) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Head Defects at 6 Weeks	91.6 defects Standard Deviation 4.38	91.3 defects Standard Deviation 10.1

SECONDARY outcome

Timeframe: 8 weeks

Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).

Sperm head defects (mean number) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=24 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Head Defects at 8 Weeks	92.3 defects Standard Deviation 4.54	88.7 defects Standard Deviation 15.1

SECONDARY outcome

Timeframe: 10 Weeks

Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).

Sperm head defects (mean number) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=29 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Head Defects at 10 Weeks	90.8 defects Standard Deviation 5.65	88.3 defects Standard Deviation 16.6

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).

Sperm neck defects (mean number) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=33 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Neck Defects at 0 Weeks	1.36 defects Standard Deviation 2.97	2.55 defects Standard Deviation 4.47

SECONDARY outcome

Timeframe: 2 weeks

Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 2 weeks (patients were not available).

Sperm neck defects (mean number) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Neck Defects at 2 Weeks	2.65 defects Standard Deviation 5.83	1.00 defects Standard Deviation 3.04

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 11 patients in the Placebo group did not have neck defects measured at 6 weeks (patients were not available).

Sperm neck defects (mean number) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=26 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Neck Defects at 6 Weeks	1.12 defects Standard Deviation 4.35	0.62 defects Standard Deviation 1.96

SECONDARY outcome

Timeframe: 8 weeks

Population: 14 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 8 weeks (patients were not available).

Sperm neck defects (mean number) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=23 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Neck Defects at 8 Weeks	1.17 defects Standard Deviation 2.66	0.50 defects Standard Deviation 1.61

SECONDARY outcome

Timeframe: 10 Weeks

Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have neck defects measured at 10 weeks (patients were not available).

Sperm neck defects (mean number) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=29 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Neck Defects at 10 Weeks	0.91 defects Standard Deviation 2.72	1.55 defects Standard Deviation 3.93

SECONDARY outcome

Timeframe: 0 weeks

Population: 6 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 0 weeks (patients were not available).

Sperm tail defects (mean number) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=31 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Tail Defects at 0 Weeks	0.13 defects Standard Deviation 0.72	1.89 defects Standard Deviation 7.86

SECONDARY outcome

Timeframe: 2 weeks

Population: 16 patients in the Duloxetine group and 3 patients in the Placebo group did not have tail defects measured at 2 weeks (patients were not available).

Sperm tail defects (mean number) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=21 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=29 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Tail Defects at 2 Weeks	0.00 defects Standard Deviation 0.00	1.66 defects Standard Deviation 7.52

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).

Sperm tail defects (mean number) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=25 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Tail Defects at 6 Weeks	0.04 defects Standard Deviation 0.20	2.64 defects Standard Deviation 11.0

SECONDARY outcome

Timeframe: 8 weeks

Population: 14 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 8 weeks (patients were not available).

Sperm tail defects (mean number) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=23 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Tail Defects at 8 Weeks	0.35 defects Standard Deviation 1.30	1.25 defects Standard Deviation 3.74

SECONDARY outcome

Timeframe: 10 Weeks

Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 10 weeks (patients were not available).

Sperm tail defects (mean number) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sperm Tail Defects at 10 Weeks	1.09 defects Standard Deviation 5.12	0.96 defects Standard Deviation 3.67

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available).

Testosterone level (ng/dL) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Testosterone Level at 0 Weeks	464 ng/dL Standard Deviation 165	448 ng/dL Standard Deviation 160

SECONDARY outcome

Timeframe: 2 weeks

Population: 8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available).

Testosterone level (ng/dL) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=29 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Testosterone Level at 2 Weeks	431 ng/dL Standard Deviation 126	482 ng/dL Standard Deviation 171

SECONDARY outcome

Timeframe: 6 weeks

Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).

Testosterone level (ng/dL) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=25 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Testosterone Level at 6 Weeks	485 ng/dL Standard Deviation 170	438 ng/dL Standard Deviation 174

SECONDARY outcome

Timeframe: 8 weeks

Population: 12 patients in the Duloxetine group and 4 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).

Testosterone level (ng/dL) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=25 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Testosterone Level at 8 Weeks	534 ng/dL Standard Deviation 237	460 ng/dL Standard Deviation 144

SECONDARY outcome

Timeframe: 10 Weeks

Population: 21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).

Testosterone level (ng/dL) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=16 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=24 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Testosterone Level at 10 Weeks	445 ng/dL Standard Deviation 165	509 ng/dL Standard Deviation 167

SECONDARY outcome

Timeframe: 0 weeks

Population: 6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).

Estrogen level (pg/mL) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=31 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=29 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Estrogen Level at 0 Weeks	51.8 pg/mL Standard Deviation 39.4	58.5 pg/mL Standard Deviation 51.9

SECONDARY outcome

Timeframe: 2 weeks

Population: 16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).

Estrogen level (pg/mL) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=25 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Estrogen Level at 2 Weeks	53.0 pg/mL Standard Deviation 37.6	44.4 pg/mL Standard Deviation 25.7

SECONDARY outcome

Timeframe: 6 weeks

Population: 16 patients in the Duloxetine group and 5 patients in the Placebo group did not have estrogen measured at 6 weeks (patients were not available).

Estrogen level (pg/mL) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=21 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Estrogen Level at 6 Weeks	45.8 pg/mL Standard Deviation 30.7	43.5 pg/mL Standard Deviation 28.2

SECONDARY outcome

Timeframe: 8 weeks

Population: 17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).

Estrogen level (pg/mL) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=26 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Estrogen Level at 8 Weeks	49.3 pg/mL Standard Deviation 31.9	39.0 pg/mL Standard Deviation 24.8

SECONDARY outcome

Timeframe: 10 Weeks

Population: 23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).

Estrogen level (pg/mL) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=14 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=24 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Estrogen Level at 10 Weeks	31.7 pg/mL Standard Deviation 12.2	133 pg/mL Standard Deviation 467

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available).

Prolactin level (ng/mL) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Prolactin Level at 0 Weeks	11.9 ng/mL Standard Deviation 5.78	12.4 ng/mL Standard Deviation 4.85

SECONDARY outcome

Timeframe: 2 weeks

Population: 8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available).

Prolactin level (ng/mL) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=29 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Prolactin Level at 2 Weeks	9.74 ng/dL Standard Deviation 3.69	11.3 ng/dL Standard Deviation 6.01

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 1 patient in the Placebo group did not have prolactin measured at 6 weeks (patients were not available).

Prolactin level (ng/mL) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=31 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Prolactin Level at 6 Weeks	10.3 ng/mL Standard Deviation 5.05	9.60 ng/mL Standard Deviation 6.01

SECONDARY outcome

Timeframe: 8 weeks

Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have prolactin measured at 8 weeks (patients were not available).

Prolactin level (ng/mL) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=25 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Prolactin Level at 8 Weeks	10.1 ng/mL Standard Deviation 4.91	8.98 ng/mL Standard Deviation 3.66

SECONDARY outcome

Timeframe: 10 Weeks

Population: 20 patients in the Duloxetine group and 5 patients in the Placebo group did not have prolactin measured at 10 weeks (patients were not available).

Prolactin level (ng/mL) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=17 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Prolactin Level at 10 Weeks	8.83 ng/mL Standard Deviation 3.31	11.6 ng/mL Standard Deviation 6.14

SECONDARY outcome

Timeframe: 0 weeks

Population: 3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available).

Luteinizing hormone level (mIU/mL) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=34 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Luteinizing Hormone Level at 0 Weeks	4.11 mIU/mL Standard Deviation 4.98	3.37 mIU/mL Standard Deviation 1.72

SECONDARY outcome

Timeframe: 2 weeks

Population: 8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available).

Luteinizing hormone level (mIU/mL) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=29 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=32 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Luteinizing Hormone Level at 2 Weeks	4.00 mIU/mL Standard Deviation 5.47	3.57 mIU/mL Standard Deviation 1.55

SECONDARY outcome

Timeframe: 6 weeks

Population: 11 patients in the Duloxetine group and 1 patient in the Placebo group did not have LH measured at 6 weeks (patients were not available).

Luteinizing hormone level (mIU/mL) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=26 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=31 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Luteinizing Hormone Level at 6 Weeks	4.51 mIU/mL Standard Deviation 5.92	3.42 mIU/mL Standard Deviation 1.43

SECONDARY outcome

Timeframe: 8 weeks

Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have LH measured at 8 weeks (patients were not available).

Luteinizing hormone level (mIU/mL) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=24 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Luteinizing Hormone Level at 8 Weeks	4.18 mIU/mL Standard Deviation 5.50	3.70 mIU/mL Standard Deviation 1.42

SECONDARY outcome

Timeframe: 10 Weeks

Population: 22 patients in the Duloxetine group and 5 patients in the Placebo group did not have LH measured at 10 weeks (patients were not available).

Luteinizing hormone level (mIU/mL) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=15 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=27 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Luteinizing Hormone Level at 10 Weeks	4.98 mIU/mL Standard Deviation 6.40	3.78 mIU/mL Standard Deviation 1.48

SECONDARY outcome

Timeframe: 0 weeks

Population: 5 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 0 weeks (patients were not available).

Follicle stimulating hormone level (mIU/mL) at 0 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=32 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=31 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Follicle Stimulating Hormone Level at 0 Weeks	6.56 mIU/mL Standard Deviation 12.3	5.26 mIU/mL Standard Deviation 4.30

SECONDARY outcome

Timeframe: 2 weeks

Population: 9 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 2 weeks (patients were not available).

Follicle stimulating hormone level (mIU/mL) at 2 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=28 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=31 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Follicle Stimulating Hormone Level at 2 Weeks	5.56 mIU/mL Standard Deviation 5.86	5.30 mIU/mL Standard Deviation 4.27

SECONDARY outcome

Timeframe: 6 weeks

Population: 16 patients in the Duloxetine group and 2 patients in the Placebo group did not have FSH measured at 6 weeks (patients were not available).

Follicle stimulating hormone level (mIU/mL) at 6 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=21 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=30 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Follicle Stimulating Hormone Level at 6 Weeks	4.57 mIU/mL Standard Deviation 5.71	5.14 mIU/mL Standard Deviation 4.39

SECONDARY outcome

Timeframe: 8 weeks

Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have FSH measured at 8 weeks (patients were not available).

Follicle stimulating hormone level (mIU/mL) at 8 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=22 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=28 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Follicle Stimulating Hormone Level at 8 Weeks	4.18 mIU/mL Standard Deviation 3.97	5.29 mIU/mL Standard Deviation 3.71

SECONDARY outcome

Timeframe: 10 Weeks

Population: 23 patients in the Duloxetine group and 6 patients in the Placebo group did not have FSH measured at 10 weeks (patients were not available).

Follicle stimulating hormone level (mIU/mL) at 10 weeks

Outcome measures

Outcome measures
Measure	Duloxetine n=14 Participants Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week	Placebo n=26 Participants Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Follicle Stimulating Hormone Level at 10 Weeks	5.54 mIU/mL Standard Deviation 5.44	5.95 mIU/mL Standard Deviation 5.43

Adverse Events

Duloxetine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research coordinator

Weill Cornell Medical College

Phone: 212-746-5385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place