Trial Outcomes & Findings for Testosterone Replacement for Male Opioid Agonist Maintained Patients (NCT NCT01873989)

Results Overview

Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Replacement Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control This arm involves watchful waiting. Waitlist control
Overall Study STARTED	8	7
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testosterone Replacement for Male Opioid Agonist Maintained Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone Replacement n=8 Participants Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control n=7 Participants This arm involves watchful waiting. Waitlist control	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	46 years STANDARD_DEVIATION 10 • n=99 Participants	48 years STANDARD_DEVIATION 11 • n=107 Participants	47 years STANDARD_DEVIATION 10 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	7 Participants n=107 Participants	15 Participants n=206 Participants
Region of Enrollment United States	8 participants n=99 Participants	7 participants n=107 Participants	15 participants n=206 Participants

PRIMARY outcome

Timeframe: 8 weeks

Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.

Outcome measures

Outcome measures
Measure	Testosterone Replacement n=8 Participants Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control n=7 Participants This arm involves watchful waiting. Waitlist control
Number of Participants Demonstrating Abstinence	5 Participants	4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10.

Outcome measures

Outcome measures
Measure	Testosterone Replacement n=8 Participants Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control n=7 Participants This arm involves watchful waiting. Waitlist control
Change in Pain Ratings	1.8 units on a scale Interval 0.9 to 2.5	1.8 units on a scale Interval 1.0 to 2.6

PRIMARY outcome

Timeframe: 8 weeks

Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26-30), mild erectile dysfunction (22-25), mild to moderate erectile dysfunction(17-21), moderate erectile dysfunction (11-16), and severe erectile dysfunction (0-10).

Outcome measures

Outcome measures
Measure	Testosterone Replacement n=8 Participants Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control n=7 Participants This arm involves watchful waiting. Waitlist control
Change in Sexual Dysfunction From Baseline to Week 8	6.95 units on a scale Standard Deviation 1.4	-1 units on a scale Standard Deviation 1.3

Adverse Events

Testosterone Replacement

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Testosterone Replacement n=8 participants at risk Testosterone replacement for hypogonadism. Testosterone replacement	Waitlist Control n=7 participants at risk This arm involves watchful waiting. Waitlist control
Musculoskeletal and connective tissue disorders Fatigue	12.5% 1/8 • Number of events 1	14.3% 1/7 • Number of events 1

Additional Information

Dr. Declan Barry

Yale University

Phone: 203-285-2708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place