Trial Outcomes & Findings for A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone (NCT NCT00522431)
NCT ID: NCT00522431
Last Updated: 2017-10-05
Results Overview
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
149 participants
Primary outcome timeframe
0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Results posted on
2017-10-05
Participant Flow
Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.
Participant milestones
| Measure |
Fortigel
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Overall Study
STARTED
|
149
|
|
Overall Study
COMPLETED
|
138
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Fortigel
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Subject non-compliance
|
1
|
|
Overall Study
Other/unknown
|
1
|
Baseline Characteristics
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
Baseline characteristics by cohort
| Measure |
Fortigel
n=149 Participants
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90Population: Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
Outcome measures
| Measure |
Fortigel
n=129 Participants
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
|
77.5 percentage of participants
Interval 70.3 to 94.7
|
SECONDARY outcome
Timeframe: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90Population: Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and \>2500 ng/dL
Outcome measures
| Measure |
Fortigel
n=129 Participants
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
≤1500 ng/dL
|
94.6 percentage of participants
|
|
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
1800-2500 ng/dL
|
1.6 percentage of participants
|
|
Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
>2500 ng/dL
|
0 percentage of participants
|
Adverse Events
Fortigel
Serious events: 5 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fortigel
n=149 participants at risk
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.67%
1/149 • Throughout the study (approximately 93 days)
|
|
Infections and infestations
Cellulitis
|
0.67%
1/149 • Throughout the study (approximately 93 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.67%
1/149 • Throughout the study (approximately 93 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/149 • Throughout the study (approximately 93 days)
|
Other adverse events
| Measure |
Fortigel
n=149 participants at risk
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
16.8%
25/149 • Throughout the study (approximately 93 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
10/149 • Throughout the study (approximately 93 days)
|
|
Infections and infestations
Sinusitis
|
4.0%
6/149 • Throughout the study (approximately 93 days)
|
|
Infections and infestations
Cellulitis
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
3/149 • Throughout the study (approximately 93 days)
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/149 • Throughout the study (approximately 93 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/149 • Throughout the study (approximately 93 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Renal and urinary disorders
Haematuria
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Investigations
Prostatic specific antigen increased
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
|
Vascular disorders
Hypertension
|
2.7%
4/149 • Throughout the study (approximately 93 days)
|
|
Psychiatric disorders
Abnormal dreams
|
1.3%
2/149 • Throughout the study (approximately 93 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication statement in clinical trial agreement
- Publication restrictions are in place
Restriction type: OTHER