Trial Outcomes & Findings for ORAL T-8 Oral Testosterone for Male Hormonal Contraception (NCT NCT01167829)
NCT ID: NCT01167829
Last Updated: 2013-09-06
Results Overview
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
baseline & day 9
Results posted on
2013-09-06
Participant Flow
Subjects were recruited through news media (website)and college campus bulletin boards in Seattle, WA. between July-September 2010. All visits were at the University of Washington, Seattle, WA.
14 subjects were screened and 2 did not meet inclusion criteria for untreated high blood pressure and peripheral arterial disease.
Participant milestones
| Measure |
Acyline and 0ral Testosterone
Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ORAL T-8 Oral Testosterone for Male Hormonal Contraception
Baseline characteristics by cohort
| Measure |
Acyline and Oral Testosterone
n=12 Participants
300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
|
|---|---|
|
Age Continuous
|
28.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.2 kg/m^2
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Body Weight
|
79.9 kg
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Follicle-stimulating hormone (FSH)
|
3.2 IU/L
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Luteinizing hormone (LH)
|
5.4 IU/L
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Testosterone
|
510 ng/dL
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Prostate-specific antigen (PSA)
|
0.91 ng/mL
STANDARD_DEVIATION 0.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline & day 9Population: per protocol
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Maximum Testosterone Concentration
Day 1
|
924 ng/dL
Geometric Coefficient of Variation 44
|
|
Maximum Testosterone Concentration
Day 9
|
741 ng/dL
Geometric Coefficient of Variation 71
|
PRIMARY outcome
Timeframe: baseline & day 9Population: per protocol
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Mean Testosterone Concentration
Day 1
|
378 ng/dL
Geometric Coefficient of Variation 45
|
|
Mean Testosterone Concentration
Day 9
|
315 ng/dL
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Maximum Dihydrotestosterone (DHT) Concentration
Day 1
|
233 ng/dL
Geometric Coefficient of Variation 49
|
|
Maximum Dihydrotestosterone (DHT) Concentration
Day 9
|
142 ng/dL
Geometric Coefficient of Variation 55
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Mean Dihydrotestosterone (DHT) Concentration
Day 1
|
96 ng/dL
Geometric Coefficient of Variation 38
|
|
Mean Dihydrotestosterone (DHT) Concentration
Day 9
|
69 ng/dL
Geometric Coefficient of Variation 41
|
SECONDARY outcome
Timeframe: baseline & day 9Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
Day 1
|
31 ng/dL
Geometric Coefficient of Variation 48
|
|
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
Day 9
|
22 ng/dL
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Mean SHGB Concentration
Day 1
|
27 ng/dL
Geometric Coefficient of Variation 46
|
|
Mean SHGB Concentration
Day 9
|
19 ng/dL
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Maximum Estradiol Concentration
Day 1
|
14 ng/dL
Geometric Coefficient of Variation 28
|
|
Maximum Estradiol Concentration
Day 9
|
9 ng/dL
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Mean Estradiol Concentration
Day 1
|
11 ng/dL
Geometric Coefficient of Variation 18
|
|
Mean Estradiol Concentration
Day 9
|
7 ng/dL
Geometric Coefficient of Variation 18
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Free T normal range 4.7-18 ng/dL
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Free T Maximum Concentration
Day 1-2
|
24 ng/dL
Geometric Coefficient of Variation 47
|
|
Free T Maximum Concentration
Day 9-10
|
21 ng/dL
Geometric Coefficient of Variation 86
|
SECONDARY outcome
Timeframe: baseline & day 9Population: per protocol
Free T normal range 4.7-18 ng/dL
Outcome measures
| Measure |
Acyline and 300 mg Oral Testosterone
n=12 Participants
300 mg oral testosterone three times daily
|
|---|---|
|
Free Testosterone Mean Concentration
Day 1-2
|
8.7 ng/dL
Geometric Coefficient of Variation 43
|
|
Free Testosterone Mean Concentration
Day 9-10
|
8.3 ng/dL
Geometric Coefficient of Variation 37
|
Adverse Events
Acyline and Oral Testosterone
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acyline and Oral Testosterone
n=12 participants at risk
300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
|
|---|---|
|
Endocrine disorders
hypogonadal symptoms
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Infections and infestations
upper respiratory infection
|
16.7%
2/12 • Number of events 2 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
General disorders
confusion
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal injury
|
16.7%
2/12 • Number of events 2 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Investigations
elevated serum aspartate aminotrasferase
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Investigations
elevated serum alanine aminotransferase
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
|
Investigations
elevated serum bilirubin
|
8.3%
1/12 • Number of events 1 • 4 months, July - October 2010
The first subject was screened 7/13/2010; the last subject exited 10/25/2010. Subjects in the study are asked about adverse events and concomitant medications at every visit.
|
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