Trial Outcomes & Findings for Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma (NCT NCT00631137)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

baseline and at 1, 3, 5, and 7 months

Results posted on

2018-08-27

Participant Flow

outpatient clinic

Participant milestones

Participant milestones
Measure	ARM 2 : Treatment Group Androgel (10g pouch/day) testosterone gel : questionnaire administration :	Arm 1: Control Group whey protein powder questionnaire administration :
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ARM 2 : Treatment Group Androgel (10g pouch/day) testosterone gel : questionnaire administration :	Arm 1: Control Group whey protein powder questionnaire administration :
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM 2 : Treatment Group n=1 Participants Androgel (10g pouch/day) testosterone gel : questionnaire administration :	Arm 1: Control Group whey protein powder questionnaire administration :	Total n=1 Participants Total of all reporting groups
Age, Customized	29 years n=99 Participants	—	29 years n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	—	0 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	—	1 Participants n=206 Participants
Region of Enrollment United States	1 participants n=99 Participants	—	1 participants n=206 Participants

PRIMARY outcome

Timeframe: baseline and at 1, 3, 5, and 7 months

Population: Only 1 subject accrued. Not enough data to analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 1, 3, 5, and 7 months

Population: Only 1 subject accrued. Not enough data to analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 1, 3, 5, and 7 months

Population: Only 1 subject accrued. Not enough data to analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 3 and 7 months

Population: Only 1 subject accrued. Not enough data to analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 1, 3, 5, and 7 months

Population: only 1 subject enrolled. Not enough to do analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: while receiving treatment

Population: only 1 subject enrolled. Not enough to do analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and at 1, 3, and 7

Population: only 1 subject enrolled. Not enough to do analysis

Outcome measures

Outcome data not reported

Adverse Events

ARM 2 : Treatment Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm 1: Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ARM 2 : Treatment Group n=1 participants at risk Androgel (10g pouch/day) testosterone gel : questionnaire administration :	Arm 1: Control Group whey protein powder questionnaire administration :
Skin and subcutaneous tissue disorders rash: acne/acneiform	100.0% 1/1 • Number of events 1 • through study completion, up to 1 year The definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.	— 0/0 • through study completion, up to 1 year The definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.

Additional Information

Jaishri Blakeley

Johns Hopkins

Phone: 410-955-8837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place