Trial Outcomes & Findings for Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men (NCT NCT00891228)
NCT ID: NCT00891228
Last Updated: 2018-05-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
24 Weeks
Results posted on
2018-05-24
Participant Flow
Participant milestones
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
34
|
|
Overall Study
COMPLETED
|
21
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
15
|
Reasons for withdrawal
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
5
|
|
Overall Study
Protocol Violation
|
3
|
1
|
2
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
5
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
Baseline Characteristics
Study of the Safety, and Sperm and Gonadotropin Suppression of a Contraceptive Gel in Normal Men
Baseline characteristics by cohort
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=32 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=33 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=34 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
Total
n=99 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
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
99 Participants
n=4 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
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
34 participants
n=5 Participants
|
99 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksOutcome measures
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=22 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=18 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=16 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
The Number of Men Who Have Suppression of Sperm Production ≤1Million/mL Million/mL When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel Applied Transdermally.
|
5 participants
|
15 participants
|
13 participants
|
SECONDARY outcome
Timeframe: 24 WeeksOutcome measures
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=22 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=18 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=16 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
The Number of Men Who Have Suppression of Sperm Production ≤3 Million/mL ≤ 3 Million/mL or Azoospermia When Using a Daily Regimen of Nestorone® Gel (0, 8 or 12 mg) and Testosterone Gel.
|
5 participants
|
15 participants
|
14 participants
|
SECONDARY outcome
Timeframe: 24 WeeksOutcome measures
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=22 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=18 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=16 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
The Number of Men Who Have Azoospermia
|
5 participants
|
14 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.
Outcome measures
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=20 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=7 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=8 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
Percent Progressive (week 24)
|
52.8 percentage of sperm
Standard Deviation 10.70
|
31.9 percentage of sperm
Standard Deviation 26.89
|
29.6 percentage of sperm
Standard Deviation 17.15
|
|
The Impact on Sperm Motility in Men Who Are Not Azoospermic Azoospermic.
Percent Non Progressive (week 24)
|
10.4 percentage of sperm
Standard Deviation 10.72
|
7.4 percentage of sperm
Standard Deviation 11.94
|
8.3 percentage of sperm
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Only subjects with the appropriate amount of data for measurement are represented in the outcome measure data table.
Outcome measures
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=21 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=6 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=8 Participants
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
The Impact on Sperm Morphology in Men Who Are Not Azoospermic
|
12.3 percentage normal morphology
Standard Deviation 3.87
|
10.8 percentage normal morphology
Standard Deviation 4.83
|
9.1 percentage normal morphology
Standard Deviation 4.64
|
Adverse Events
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Gel 10 g and Nestorone® 0 mg Per Day
n=32 participants at risk
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver 4 mL of gel containing 0 mg of Nestorone® by pressing two times with the 2 mL dispenser head.
|
Testosterone Gel 10 g and Nestorone® 8 mg Per Day
n=33 participants at risk
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg NES mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 8 mg of Nestorone®. For 8 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (2 mg Nestorone® mL gel) by pressing two times with 2 mL dispenser head.
|
Testosterone Gel 10 g Plus Nestorone® Gel 12 mg Per Day
n=34 participants at risk
Two individual packets of Testosterone Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of Testosterone on the skin. Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
Testosterone: Two individual packets of T Gel, each with 5 g of gel applied to each arm delivering a total of 100 mg of T on the skin daily.
Nestorone®: Nestorone® Gel will be delivered by a pump configured to deliver a metered volume of Nestorone® Gel containing 12 mg of Nestorone®. For 12 mg Nestorone® dose; Nestorone® Gel will be delivered in 4 mL volume (3 mg Nestorone®/mL gel) by pressing two times with 2 mL dispenser head.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency anaemia
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Eye disorders
Pinguecula
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Haematochezia
|
3.1%
1/32 • Number of events 1
|
0.00%
0/33
|
0.00%
0/34
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.1%
1/32 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Stomach Discomfort
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Stomatitis
|
3.1%
1/32 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Toothache
|
3.1%
1/32 • Number of events 1
|
3.0%
1/33 • Number of events 1
|
0.00%
0/34
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
Application site discolouration
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
General disorders
Chest pain
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
General disorders
Energy Increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
General disorders
Fatigue
|
3.1%
1/32
|
3.0%
1/33
|
0.00%
0/34
|
|
General disorders
Irritability
|
3.1%
1/32
|
3.0%
1/33
|
0.00%
0/34
|
|
General disorders
Oedema peripheral
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
General disorders
Pain
|
3.1%
1/32
|
3.0%
1/33
|
0.00%
0/34
|
|
General disorders
Pyrexia
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Immune system disorders
Hypersensitivity
|
6.2%
2/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Immune system disorders
Multiple allergies
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/32
|
6.1%
2/33
|
0.00%
0/34
|
|
Infections and infestations
Cellulitis
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Folliculitis
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Influenza
|
9.4%
3/32
|
12.1%
4/33
|
2.9%
1/34
|
|
Infections and infestations
Nasopharyngitis
|
21.9%
7/32
|
12.1%
4/33
|
20.6%
7/34
|
|
Infections and infestations
Onychomycosis
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Infections and infestations
Oral herpes
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Pareonychia
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Pharyngitis bacterial
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Infections and infestations
Sinusitis
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
3/32
|
9.1%
3/33
|
8.8%
3/34
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Infections and infestations
Viral infection
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
Back injury
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
Injury
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Post traumatic pain
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
6.2%
2/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Investigations
Blood cholesterol increased
|
3.1%
1/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Investigations
Blood glucose increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Investigations
Blood iron decreased
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Blood potassium increased
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Blood triglycerides increased
|
3.1%
1/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Heart rate increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Investigations
semen volume increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Investigations
Sperm count increased
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Investigations
Transaminases increased
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Investigations
Weight increased
|
3.1%
1/32
|
12.1%
4/33
|
5.9%
2/34
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32
|
3.0%
1/33
|
5.9%
2/34
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32
|
6.1%
2/33
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Nervous system disorders
Dizziness
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Nervous system disorders
headache
|
28.1%
9/32
|
18.2%
6/33
|
5.9%
2/34
|
|
Nervous system disorders
Somnolence
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Psychiatric disorders
aggression
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Psychiatric disorders
depression
|
3.1%
1/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Psychiatric disorders
Libido decreased
|
3.1%
1/32
|
6.1%
2/33
|
0.00%
0/34
|
|
Psychiatric disorders
insomnia
|
6.2%
2/32
|
6.1%
2/33
|
5.9%
2/34
|
|
Psychiatric disorders
libido increased
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Psychiatric disorders
mood altered
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Psychiatric disorders
mood swings
|
0.00%
0/32
|
6.1%
2/33
|
2.9%
1/34
|
|
Psychiatric disorders
nightmare
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Renal and urinary disorders
pollakiuria
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Reproductive system and breast disorders
ejaculation disorder
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Reproductive system and breast disorders
genital rash
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Reproductive system and breast disorders
gynaecomastia
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Reproductive system and breast disorders
nipple pain
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Reproductive system and breast disorders
varicocele
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
6.2%
2/32
|
6.1%
2/33
|
5.9%
2/34
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary congestion
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Respiratory, thoracic and mediastinal disorders
sinus congestion
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
acne
|
28.1%
9/32
|
21.2%
7/33
|
14.7%
5/34
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.1%
1/32
|
6.1%
2/33
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
heat rash
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/32
|
3.0%
1/33
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Surgical and medical procedures
mole excision
|
0.00%
0/32
|
0.00%
0/33
|
2.9%
1/34
|
|
Surgical and medical procedures
oral surgery
|
3.1%
1/32
|
0.00%
0/33
|
0.00%
0/34
|
|
Surgical and medical procedures
tooth repair
|
0.00%
0/32
|
3.0%
1/33
|
0.00%
0/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place