Trial Outcomes & Findings for Aromatase Inhibitors in the Treatment of Male Infertility (NCT NCT00440180)

Results Overview

Partner pregnancy rate during study participation

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

4 months

Results posted on

2016-04-06

Participant milestones
Measure	Placebo Placebo once daily	Anastrozole 1 milligram daily
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Aromatase Inhibitors in the Treatment of Male Infertility

Baseline characteristics by cohort
Measure	Placebo n=10 Participants Placebo once daily	Anastrozole n=10 Participants 1 milligram daily	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

Timeframe: 4 months

Partner pregnancy rate during study participation

Outcome measures
Measure	Placebo n=10 Participants Placebo once daily	Anastrozole n=10 Participants 1 milligram daily
Pregnancy Rate	0 participants partner	1 participants partner

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events
Measure	Placebo n=20 participants at risk；n=10 participants at risk Placebo once daily	Anastrozole n=20 participants at risk；n=10 participants at risk 1 milligram daily
Blood and lymphatic system disorders Axillary Lymphadenopathy	0.00% 0/10	10.0% 1/10 • Number of events 1

Other adverse events
Measure	Placebo n=20 participants at risk；n=10 participants at risk Placebo once daily	Anastrozole n=20 participants at risk；n=10 participants at risk 1 milligram daily
General disorders Increased Liver Enzymes	10.0% 2/20 • Number of events 2	10.0% 2/20 • Number of events 2
General disorders Headache	5.0% 1/20 • Number of events 1	25.0% 5/20 • Number of events 5

University of Utah

Phone: 801-213-2845