Trial Outcomes & Findings for Oral T7 Oral Testosterone in Man (NCT NCT00842751)

Results Overview

Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

0,1,2,4,8,and 12-hour post dose

Results posted on

2014-01-13

Participant Flow

Men age 18-52 in good health were recruited through local newspapers and college campus flyers.

12 subjects were screened; 11 enrolled (1 did not meet inclusion criteria-abnormal liver function test at baseline and excessive alcohol use). Each subject was administered each of the three treatments over a 6-week period with 1 week of no treatment (wash-out) between each of the treatment period.

Participant milestones

Participant milestones
Measure	Acyline + Testosterone Undecanoate + Placebo Finasteride Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral T7 Oral Testosterone in Man

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=11 Participants
Age, Continuous	32 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Weight	80 kg STANDARD_DEVIATION 13 • n=5 Participants
Height	181 cm STANDARD_DEVIATION 7 • n=5 Participants
Body Mass Index (BMI)	24 kg/m2 STANDARD_DEVIATION 3 • n=5 Participants
Serum testosterone concentration	405 ng/dL STANDARD_DEVIATION 14 • n=5 Participants
Serum dihydrotestosterone concentration	32 ng/dL STANDARD_DEVIATION 12 • n=5 Participants
Serum oestradiol concentration	15 pg/mL STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: 0,1,2,4,8,and 12-hour post dose

Population: All participant received all treatments and is, therefore, included in the analysis population for all groups.

Area under the curve of serum testosterone Pharmacokinetic measures time-weighted mean concentration calculated as area under the concentration curve (AUC) divided by time from initiation of dosing for the morning dose and corrected for differences in baseline hormone concentration.

Outcome measures

Outcome measures
Measure	Acyline +Testosterone Undecanoate + Placebo n=11 Participants Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride	Acyline +Testosterone Undecanoate + 0.5mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally	Acyline +Testosterone Undecanoate + 1mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
Maximum Testosterone Concentration	471 ng*hr/dL Interval 381.0 to 581.0	444 ng*hr/dL Interval 358.0 to 551.0	543 ng*hr/dL Interval 439.0 to 671.0

PRIMARY outcome

Timeframe: 0,1,2,4,8,and 12-hour post dose

Population: All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.

Area under the curve of serum dihydrotestosterone

Outcome measures

Outcome measures
Measure	Acyline +Testosterone Undecanoate + Placebo n=11 Participants Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride	Acyline +Testosterone Undecanoate + 0.5mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally	Acyline +Testosterone Undecanoate + 1mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
Serum Dihydrotestosterone Concentration	154 ng*hr/dL Interval 125.0 to 190.0	118 ng*hr/dL Interval 96.0 to 146.0	125 ng*hr/dL Interval 102.0 to 154.0

PRIMARY outcome

Timeframe: 0,1,2,4,8,and 12-hour post dose

Population: All participants received all treatment, and is therefore, included in the analysis population for all three treatment groups.

Area under the curve of serum estradiol

Outcome measures

Outcome measures
Measure	Acyline +Testosterone Undecanoate + Placebo n=11 Participants Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride	Acyline +Testosterone Undecanoate + 0.5mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally	Acyline +Testosterone Undecanoate + 1mg Finasteride n=11 Participants Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
Serum Estradiol Concentration	7.9 ng*hr/dL Interval 6.4 to 9.7	6.5 ng*hr/dL Interval 5.2 to 8.0	7.2 ng*hr/dL Interval 5.8 to 8.9

Adverse Events

First Intervention

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Second Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Third Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	First Intervention n=11 participants at risk Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally	Second Intervention n=11 participants at risk Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally	Third Intervention n=11 participants at risk Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
Reproductive system and breast disorders Hot flashes	9.1% 1/11 • Number of events 1	0.00% 0/11	9.1% 1/11 • Number of events 1
Reproductive system and breast disorders Testicular Pain	9.1% 1/11 • Number of events 1	9.1% 1/11 • Number of events 1	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Upset Stomach & Reflux	9.1% 1/11 • Number of events 1	9.1% 1/11 • Number of events 1	0.00% 0/11
Psychiatric disorders Depression	9.1% 1/11 • Number of events 1	0.00% 0/11	9.1% 1/11 • Number of events 1
Nervous system disorders Headache	9.1% 1/11 • Number of events 1	0.00% 0/11	0.00% 0/11

Additional Information

John Amory, MD

University of Washington, Dept. of Medicine

Phone: (206) 616-1727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place