Trial Outcomes & Findings for Intranasal Delivery of Testosterone and Its Effect on Doping Markers (NCT NCT02611154)

Results Overview

Participants were instructed to follow this dosing pattern: Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28 The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29. Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

4 weeks of dosing for each participant

Results posted on

2020-02-11

Participant Flow

Recruitment for this study began in November 2015 and ended December 2015. The final participant was enrolled on 03DEC2015 and completed the study on 19JAN2016.

Participant milestones

Participant milestones
Measure	Intranasal Testosterone All participants will be receiving intranasal testosterone and will follow the same study procedures. Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Delivery of Testosterone and Its Effect on Doping Markers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intranasal Testosterone n=5 Participants All participants will be receiving intranasal testosterone and will follow the same study procedures. Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex/Gender, Customized Male Participants	5 participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 weeks of dosing for each participant

Participants were instructed to follow this dosing pattern: Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28 The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29. Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose

Outcome measures

Outcome measures
Measure	Urine Steroid Profile - Day 6 n=5 Participants Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 13 n=5 Participants Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 21 n=5 Participants Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 28 n=5 Participants Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 29 n=5 Participants Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.	Urine Steroid Profile - Day 30 n=5 Participants Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.	Urine Steroid Profile - Day 35 n=5 Participants Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.	Urine Steroid Profile - Day 42 n=5 Participants Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
Steroid Levels in Urine Steroid Profile Testosterone	69.5773456 ng/mL Standard Deviation 35.54601116	138.0291641 ng/mL Standard Deviation 141.9066157	163.117081 ng/mL Standard Deviation 109.276721	107.7160658 ng/mL Standard Deviation 113.703136	14.15587072 ng/mL Standard Deviation 4.228012086	21.42280994 ng/mL Standard Deviation 14.29364856	32.9077285 ng/mL Standard Deviation 13.76180063	28.14492389 ng/mL Standard Deviation 6.661553442
Steroid Levels in Urine Steroid Profile Epitestosterone	14.54132527 ng/mL Standard Deviation 7.954646945	16.23444899 ng/mL Standard Deviation 11.98868156	10.08654906 ng/mL Standard Deviation 4.588211806	9.736167767 ng/mL Standard Deviation 4.015340993	12.22899541 ng/mL Standard Deviation 4.434891082	16.38534782 ng/mL Standard Deviation 4.918171284	27.76476978 ng/mL Standard Deviation 16.66310752	32.56796986 ng/mL Standard Deviation 10.94213563
Steroid Levels in Urine Steroid Profile Androsterone	2780.422993 ng/mL Standard Deviation 1545.144279	3147.357191 ng/mL Standard Deviation 2520.278196	3377.718911 ng/mL Standard Deviation 1511.306185	4014.439418 ng/mL Standard Deviation 4846.667258	1098.544542 ng/mL Standard Deviation 430.6835869	1689.228939 ng/mL Standard Deviation 968.2213645	2292.971167 ng/mL Standard Deviation 853.7596469	1561.824479 ng/mL Standard Deviation 663.1827091
Steroid Levels in Urine Steroid Profile Etiocholanolone	3420.811467 ng/mL Standard Deviation 2957.358109	2984.088377 ng/mL Standard Deviation 2078.022714	3168.249168 ng/mL Standard Deviation 1630.873996	4614.568182 ng/mL Standard Deviation 7192.193898	1154.779419 ng/mL Standard Deviation 460.2075499	1810.282342 ng/mL Standard Deviation 1552.137347	2612.685992 ng/mL Standard Deviation 2105.416619	1281.752255 ng/mL Standard Deviation 372.3518874
Steroid Levels in Urine Steroid Profile 5αAdiol	81.50246345 ng/mL Standard Deviation 28.87216828	70.09892435 ng/mL Standard Deviation 31.91867777	79.92660959 ng/mL Standard Deviation 19.82671546	83.39693284 ng/mL Standard Deviation 59.00306611	37.53345262 ng/mL Standard Deviation 7.673138406	51.7003489 ng/mL Standard Deviation 22.77519196	60.19484767 ng/mL Standard Deviation 21.91151504	56.94343765 ng/mL Standard Deviation 30.25653073
Steroid Levels in Urine Steroid Profile 5βAdiol	323.5235566 ng/mL Standard Deviation 95.27658018	370.2752839 ng/mL Standard Deviation 244.8399242	386.6496467 ng/mL Standard Deviation 178.3061711	369.209311 ng/mL Standard Deviation 243.4060107	145.5896139 ng/mL Standard Deviation 54.18663296	158.5303528 ng/mL Standard Deviation 90.57253904	166.0185686 ng/mL Standard Deviation 97.42880397	85.54384971 ng/mL Standard Deviation 17.46215146

SECONDARY outcome

Timeframe: Day 1, Day 3, Day 5

Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, "suspicious" is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL.

Outcome measures

Outcome measures
Measure	Urine Steroid Profile - Day 6 n=5 Participants Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 13 n=5 Participants Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 21 n=5 Participants Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 28 n=5 Participants Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 29 n=5 Participants Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.	Urine Steroid Profile - Day 30 n=5 Participants Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.	Urine Steroid Profile - Day 35 Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.	Urine Steroid Profile - Day 42 Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 0 and Day 19

Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation.

Outcome measures

Outcome measures
Measure	Urine Steroid Profile - Day 6 n=5 Participants Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 13 n=5 Participants Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 21 Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 28 Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.	Urine Steroid Profile - Day 29 Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.	Urine Steroid Profile - Day 30 Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.	Urine Steroid Profile - Day 35 Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.	Urine Steroid Profile - Day 42 Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
Testosterone Level in Blood as Measured for Safety	408.4 ng/mL Interval 300.0 to 1080.0	373.4 ng/mL Interval 300.0 to 1080.0	—	—	—	—	—	—

Adverse Events

Intranasal Testosterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Geoffry Miller

Sports Medicine Research & Testing Laboratory

Phone: 801-994-9519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place