NCT02722278 · ADVERSE EVENTS

Adverse events

A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men · Source last updated 2018-02-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 9 months
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Oral Testosterone Undecanoate 166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID). Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.	2 / 166	31 / 166	0 / 166
Axiron Testosterone Topical Solution 56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning. Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.	0 / 55	8 / 55	0 / 56

Group identifiers: EG000: Oral Testosterone Undecanoate · EG001: Axiron Testosterone Topical Solution

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Periumbilical abscess

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
5
num At Risk
166
num Events
5
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
High Density Lipoprotein Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Blood triglycerides increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
1
num At Risk
55
num Events
1
term
Blood pressure increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Prostatic specific antigen increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
166
num Events
4
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
166
num Events
3
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
166
num Events
3
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Eructation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
166
num Events
6
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Upper respiratory tract infection

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
166
description
166 subjects received oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID). Oral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
id
EG000
other Num Affected
31
other Num At Risk
166
serious Num Affected
2
serious Num At Risk
166
title
Oral Testosterone Undecanoate
deaths Num Affected
0
deaths Num At Risk
56
description
56 subjects were randomly assigned to the Axiron treatment group and began treatment at a dose of 60 mg every morning. Axiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \< 350 ng/dL, decreased if \> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
id
EG001
other Num Affected
8
other Num At Risk
55
serious Num Affected
0
serious Num At Risk
55
title
Axiron Testosterone Topical Solution

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
5
num At Risk
166
num Events
5
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
High Density Lipoprotein Decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Blood triglycerides increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
1
num At Risk
55
num Events
1
term
Blood pressure increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Prostatic specific antigen increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
4
num At Risk
166
num Events
4
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
166
num Events
3
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
166
num Events
3
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
166
num Events
2
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Eructation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
6
num At Risk
166
num Events
6
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Upper respiratory tract infection

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
166
num Events
1
group Id
EG001
num Affected
0
num At Risk
55
num Events
0
term
Periumbilical abscess

time Frame

9 months

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Preserved source evidence · Not medical advice