Trial Outcomes & Findings for To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone (NCT NCT00706719)
NCT ID: NCT00706719
Last Updated: 2015-08-19
Results Overview
Total sperm concentration was measured.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Results posted on
2015-08-19
Participant Flow
Participant milestones
| Measure |
Group A Testim (Topical Testosterone)
1% Testim gel applied once daily
|
Group B Androxal no Washout
25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone
|
Group C Androxal With Wash Out
25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
5
|
|
Overall Study
COMPLETED
|
5
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Baseline characteristics by cohort
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=7 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
Group C Androxal Wash Out
n=5 Participants
25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
|
Total
n=17 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 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
|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 8.99 • n=7 Participants
|
56.4 years
STANDARD_DEVIATION 23.8 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 7.72 • 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
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
17 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)Population: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Total sperm concentration was measured.
Outcome measures
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=6 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
|---|---|---|
|
Sperm Concentration
Baseline
|
0.54 millions sperm/mL
Standard Deviation 0.74
|
72.8 millions sperm/mL
Standard Deviation 92.7
|
|
Sperm Concentration
Month 3
|
3.00 millions sperm/mL
Standard Deviation 5.20
|
182.6 millions sperm/mL
Standard Deviation 115.5
|
|
Sperm Concentration
Month 6
|
23.14 millions sperm/mL
Standard Deviation 30.67
|
168.5 millions sperm/mL
Standard Deviation 92.9
|
|
Sperm Concentration
Follow-Up (Month 7)
|
21.03 millions sperm/mL
Standard Deviation 28.90
|
164.0 millions sperm/mL
Standard Deviation 71.2
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)Population: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Motile total sperm count was measured.
Outcome measures
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=6 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
|---|---|---|
|
Motile Total Sperm Count
Baseline
|
0.3 millions sperm
Standard Deviation 0.48
|
99.0 millions sperm
Standard Deviation 159.6
|
|
Motile Total Sperm Count
Month 3
|
2.42 millions sperm
Standard Deviation 5.41
|
214.7 millions sperm
Standard Deviation 166.0
|
|
Motile Total Sperm Count
Month 6
|
40.4 millions sperm
Standard Deviation 55.3
|
146.9 millions sperm
Standard Deviation 120.0
|
|
Motile Total Sperm Count
Follow-Up (Month 7)
|
38 millions sperm
Standard Deviation 52.5
|
100.3 millions sperm
Standard Deviation 103.8
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)Population: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
Semen volume was measured.
Outcome measures
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=6 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
|---|---|---|
|
Semen Volume
Follow-Up (Month 7)
|
3.34 mL
Standard Deviation 0.83
|
2.40 mL
Standard Deviation 0.58
|
|
Semen Volume
Baseline
|
2.34 mL
Standard Deviation 1.43
|
2.23 mL
Standard Deviation 0.81
|
|
Semen Volume
Month 3
|
2.88 mL
Standard Deviation 1.40
|
2.45 mL
Standard Deviation 1.31
|
|
Semen Volume
Month 6
|
1.90 mL
Standard Deviation 1.03
|
2.48 mL
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)Population: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
LH levels were measured.
Outcome measures
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=6 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
|---|---|---|
|
Luteinizing Hormone (LH) Levels
Baseline
|
3.40 mIU/mL
Standard Deviation 2.14
|
2.92 mIU/mL
Standard Deviation 1.69
|
|
Luteinizing Hormone (LH) Levels
Month 3
|
0.88 mIU/mL
Standard Deviation 1.39
|
5.70 mIU/mL
Standard Deviation 3.22
|
|
Luteinizing Hormone (LH) Levels
Month 6
|
0.60 mIU/mL
Standard Deviation 0.58
|
6.12 mIU/mL
Standard Deviation 3.15
|
|
Luteinizing Hormone (LH) Levels
Follow-Up (Month 7)
|
2.68 mIU/mL
Standard Deviation 0.48
|
2.47 mIU/mL
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Follow-Up (Month 7)Population: Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study.
FSH levels were measured.
Outcome measures
| Measure |
Group A Testim
n=5 Participants
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=6 Participants
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
|---|---|---|
|
Follicle Stimulating Hormone (FSH) Levels
Baseline
|
3.38 mIU/mL
Standard Deviation 0.74
|
1.58 mIU/mL
Standard Deviation 0.74
|
|
Follicle Stimulating Hormone (FSH) Levels
Month 3
|
1.06 mIU/mL
Standard Deviation 1.12
|
4.53 mIU/mL
Standard Deviation 2.36
|
|
Follicle Stimulating Hormone (FSH) Levels
Month 6
|
0.9 mIU/mL
Standard Deviation 0.51
|
5.48 mIU/mL
Standard Deviation 2.46
|
|
Follicle Stimulating Hormone (FSH) Levels
Follow-Up (Month 7)
|
3.6 mIU/mL
Standard Deviation 1.20
|
2.38 mIU/mL
Standard Deviation 0.95
|
Adverse Events
Group A Testim
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B Androxal no Wash Out
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Androxal Wash Out
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A Testim
n=5 participants at risk
1% Testim gel applied daily
|
Group B Androxal no Wash Out
n=7 participants at risk
25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months
|
Androxal Wash Out
n=5 participants at risk
25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/5
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
erythema
|
0.00%
0/5
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/5
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
worsening depression
|
0.00%
0/5
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
blurred vision
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Vascular disorders
vasomotor flushing
|
0.00%
0/5
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER