Trial Outcomes & Findings for Time to Eugonadal Range, Time to Steady State and Drying Time (NCT NCT01228071)

Results Overview

The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

24 hours

Results posted on

2017-10-05

Participant Flow

This multicenter, open-label, single-arm phase 3B trial was initiated on November 9, 2010 and completed on May 6, 2011 in the United States.

After the 3-week screening period and fulfilling the eligibility criteria, 34 hypogonadal men were enrolled in the study.

Participant milestones

Participant milestones
Measure	40 mg Daily Dose of Testosterone Gel 2% testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	40 mg Daily Dose of Testosterone Gel 2% testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Time to Eugonadal Range, Time to Steady State and Drying Time

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	40 mg Daily Dose of Testosterone Gel 2% n=34 Participants testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Age, Categorical <=18 years	0 Participants n=113 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=113 Participants
Age, Categorical >=65 years	0 Participants n=113 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 10.01 • n=113 Participants
Sex: Female, Male Female	0 Participants n=113 Participants
Sex: Female, Male Male	34 Participants n=113 Participants
Region of Enrollment United States	34 participants n=113 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.

The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.

Outcome measures

Outcome measures
Measure	40 mg Daily Dose of Testosterone Gel 2% n=24 Participants testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Time to Target Eugonadal Range	2.85 hours Interval 1.91 to 4.25

PRIMARY outcome

Timeframe: 14 days

Population: The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.

Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.

Outcome measures

Outcome measures
Measure	40 mg Daily Dose of Testosterone Gel 2% n=31 Participants testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Time to Steady State (SS)	1.13 days Interval 0.68 to 3.4

PRIMARY outcome

Timeframe: 1 day; drying time measured following gel application on Day 14

Population: The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.

Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.

Outcome measures

Outcome measures
Measure	40 mg Daily Dose of Testosterone Gel 2% n=31 Participants testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
Gel Drying Time	2.4 minutes Interval 1.7 to 3.4

Adverse Events

EN3350 (Testosterone Gel 2%)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EN3350 (Testosterone Gel 2%) n=34 participants at risk testosterone gel 2% testosterone gel 2% : 40 mg testosterone gel 2%
General disorders Application site dryness	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
General disorders Application site rash	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
Gastrointestinal disorders Diarrhoea	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
Nervous system disorders Headache	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
Respiratory, thoracic and mediastinal disorders Productive cough	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
Respiratory, thoracic and mediastinal disorders Throat irritation	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS). All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.

Additional Information

Clinical Trial Coordinator

Endo Pharmaceutical, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60