Trial Outcomes & Findings for PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue (NCT NCT00490555)

NCT ID: NCT00490555

Last Updated: 2013-11-15

Results Overview

PSA level week 10 end of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2013-11-15

Participant Flow

Healthy male volunteers, 25-55 yr old, were recruited via advertisement: flyers on University campus and newspaper ads.

Participant milestones

Measure	1) Placebo Placebo gel + Placebo pill + placebo DMPA	2) Testosterone (T) Gel Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA	3) T Gel+Dutasteride Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+DMPA Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
Overall Study STARTED	8	8	9	7
Overall Study COMPLETED	8	8	7	7
Overall Study NOT COMPLETED	0	0	2	0

Reasons for withdrawal

Measure	1) Placebo Placebo gel + Placebo pill + placebo DMPA	2) Testosterone (T) Gel Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA	3) T Gel+Dutasteride Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+DMPA Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
Overall Study noncompliant with drug administration	0	0	2	0

Baseline Characteristics

PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue

Baseline characteristics by cohort

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=8 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=9 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)	Total n=32 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	41 years STANDARD_DEVIATION 7.72 • n=5 Participants	37 years STANDARD_DEVIATION 6.19 • n=7 Participants	37 years STANDARD_DEVIATION 8.45 • n=5 Participants	39 years STANDARD_DEVIATION 10.11 • n=4 Participants	39 years STANDARD_DEVIATION 3.46 • n=21 Participants
Sex/Gender, Customized Female	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Sex/Gender, Customized Male	8 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	32 participants n=21 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	7 participants n=4 Participants	32 participants n=21 Participants
Luteinizing Hormone (LH)	4.0 IU/liter n=5 Participants	3.9 IU/liter n=7 Participants	5.3 IU/liter n=5 Participants	3.2 IU/liter n=4 Participants	4.1 IU/liter n=21 Participants
Follical-stimulating hormone (FSH)	3.6 IU/liter n=5 Participants	3.3 IU/liter n=7 Participants	4.0 IU/liter n=5 Participants	2.8 IU/liter n=4 Participants	3.4 IU/liter n=21 Participants
SHBG	33 nmol/liter n=5 Participants	36 nmol/liter n=7 Participants	38 nmol/liter n=5 Participants	33 nmol/liter n=4 Participants	35 nmol/liter n=21 Participants
Testosterone (T) concentration	3.9 ng/mL n=5 Participants	3.9 ng/mL n=7 Participants	4.8 ng/mL n=5 Participants	4.0 ng/mL n=4 Participants	4.1 ng/mL n=21 Participants
Dihydrotestosterone (DHT)	0.5 ng/mL n=5 Participants	0.6 ng/mL n=7 Participants	0.7 ng/mL n=5 Participants	0.6 ng/mL n=4 Participants	0.6 ng/mL n=21 Participants
Prostate-Specific Antigen (PSA)	0.7 ng/mL n=5 Participants	0.7 ng/mL n=7 Participants	0.9 ng/mL n=5 Participants	0.5 ng/mL n=4 Participants	0.7 ng/mL n=21 Participants
Prostate volume	25 ml n=5 Participants	15 ml n=7 Participants	15 ml n=5 Participants	19 ml n=4 Participants	18 ml n=21 Participants

PRIMARY outcome

Timeframe: 10 weeks

PSA level week 10 end of treatment

Outcome measures

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=7 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Prostate-specific Antigen (PSA)	0.8 ng/mL Interval 0.7 to 1.2	0.9 ng/mL Interval 0.3 to 1.2	0.7 ng/mL Interval 0.7 to 1.1	0.4 ng/mL Interval 0.4 to 0.6

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=7 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Testosterone Concentration	4.0 ng/mL Interval 2.9 to 5.6	4.4 ng/mL Interval 3.2 to 6.2	7.0 ng/mL Interval 4.4 to 12.4	1.8 ng/mL Interval 1.3 to 2.9

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=7 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Dihydrotestosterone (DHT) Concentration	0.5 ng/mL Interval 0.4 to 0.6	1.8 ng/mL Interval 1.2 to 2.5	0.5 ng/mL Interval 0.3 to 0.5	0.6 ng/mL Interval 0.2 to 1.8

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=7 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Androstenedione (AED)	0.9 ng/mL Interval 0.8 to 1.1	0.9 ng/mL Interval 0.8 to 1.3	1.8 ng/mL Interval 1.3 to 3.7	0.7 ng/mL Interval 0.6 to 1.0

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	1) Placebo n=8 Participants Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=7 Participants Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 Participants Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
Dehydroepiandrosterone (DHEA)	4.3 ng/mL Interval 2.7 to 5.5	3.5 ng/mL Interval 2.0 to 7.5	3.8 ng/mL Interval 3.8 to 6.3	3.2 ng/mL Interval 2.1 to 4.0

Adverse Events

1) Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

2) Testosterone Gel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

3) T Gel +Dutasteride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

4) T Gel+ DMPA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	1) Placebo n=8 participants at risk Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA	2) Testosterone Gel n=7 participants at risk Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA	3) T Gel +Dutasteride n=9 participants at risk Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA	4) T Gel+ DMPA n=7 participants at risk Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
General disorders Fatigue	12.5% 1/8 • Number of events 1	0.00% 0/7	0.00% 0/9	0.00% 0/7
General disorders headache	0.00% 0/8	14.3% 1/7 • Number of events 1	0.00% 0/9	14.3% 1/7 • Number of events 1
Skin and subcutaneous tissue disorders rash	0.00% 0/8	14.3% 1/7 • Number of events 1	0.00% 0/9	0.00% 0/7
Skin and subcutaneous tissue disorders abscess	0.00% 0/8	0.00% 0/7	11.1% 1/9 • Number of events 1	0.00% 0/7

Additional Information

Dr. Stephanie Page

University of Washington

Phone: 2066160483

Email: page@u.washington.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place