Trial Outcomes & Findings for A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants (NCT NCT01725451)
NCT ID: NCT01725451
Last Updated: 2014-10-16
Results Overview
The AUC from time 0 to 72 hours \[AUC (0-72)\] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug
Results posted on
2014-10-16
Participant Flow
Participant milestones
| Measure |
Sequence 1
30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 2
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 3
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 4
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
|---|---|---|---|---|
|
Period 1
STARTED
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8
|
7
|
8
|
7
|
|
Period 1
COMPLETED
|
7
|
7
|
8
|
7
|
|
Period 1
NOT COMPLETED
|
1
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0
|
0
|
0
|
|
Washout From Period 1
STARTED
|
7
|
7
|
8
|
7
|
|
Washout From Period 1
COMPLETED
|
7
|
7
|
8
|
7
|
|
Washout From Period 1
NOT COMPLETED
|
0
|
0
|
0
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0
|
|
Period 2
STARTED
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7
|
7
|
8
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7
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Period 2
COMPLETED
|
7
|
7
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8
|
7
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout From Period 2
STARTED
|
7
|
7
|
8
|
7
|
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Washout From Period 2
COMPLETED
|
7
|
7
|
8
|
7
|
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Washout From Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
7
|
7
|
8
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7
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Period 3
COMPLETED
|
7
|
7
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8
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7
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|
Period 3
NOT COMPLETED
|
0
|
0
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0
|
0
|
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Washout From Period 3
STARTED
|
7
|
7
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8
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7
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Washout From Period 3
COMPLETED
|
7
|
6
|
7
|
7
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Washout From Period 3
NOT COMPLETED
|
0
|
1
|
1
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0
|
|
Period 4
STARTED
|
7
|
6
|
7
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7
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Period 4
COMPLETED
|
7
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6
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6
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7
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Period 4
NOT COMPLETED
|
0
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0
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1
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0
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Washout From Period 4
STARTED
|
7
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6
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6
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7
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Washout From Period 4
COMPLETED
|
7
|
6
|
6
|
7
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Washout From Period 4
NOT COMPLETED
|
0
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0
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0
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0
|
|
Period 5
STARTED
|
7
|
6
|
6
|
7
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Period 5
COMPLETED
|
7
|
6
|
6
|
7
|
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Period 5
NOT COMPLETED
|
0
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0
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0
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0
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Washout From Period 5
STARTED
|
7
|
6
|
6
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7
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Washout From Period 5
COMPLETED
|
7
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6
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6
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7
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Washout From Period 5
NOT COMPLETED
|
0
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0
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0
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0
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|
Period 6
STARTED
|
7
|
6
|
6
|
7
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Period 6
COMPLETED
|
7
|
6
|
6
|
7
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Period 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 2
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 3
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
Sequence 4
30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Washout From Period 3
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Washout From Period 3
Adverse Event
|
0
|
1
|
0
|
0
|
|
Period 4
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
Baseline characteristics by cohort
| Measure |
Testosterone 2% Solution
n=30 Participants
Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
|
|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 7.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native/White
|
1 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
28 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=39 Participants
|
|
Screening Testosterone
|
290.8 nanograms per deciliter (ng/dL)
STANDARD_DEVIATION 78.2 • n=39 Participants
|
PRIMARY outcome
Timeframe: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drugPopulation: All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.
The AUC from time 0 to 72 hours \[AUC (0-72)\] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
Outcome measures
| Measure |
Testosterone Unshaved
n=27 Participants
No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
|
Testosterone Unshaved + Deodorant Spray
n=29 Participants
Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Spray
n=29 Participants
Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Stick
n=28 Participants
Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Shaved
n=26 Participants
No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
|
Testosterone Shaved + Deodorant Antiperspirant Spray
n=26 Participants
Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
|
2120 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 164.0
|
2400 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 196.0
|
2970 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 92.0
|
2880 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 129.0
|
3110 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 129.0
|
2070 nanograms* hours per deciliter (ng*h/dL)
Geometric Coefficient of Variation 1733.0
|
PRIMARY outcome
Timeframe: Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drugPopulation: All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.
The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.
Outcome measures
| Measure |
Testosterone Unshaved
n=29 Participants
No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
|
Testosterone Unshaved + Deodorant Spray
n=29 Participants
Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Spray
n=29 Participants
Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Stick
n=28 Participants
Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Shaved
n=26 Participants
No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
|
Testosterone Shaved + Deodorant Antiperspirant Spray
n=26 Participants
Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
|
214 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 97.0
|
209 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 119.0
|
234 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 106.0
|
202 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 97.0
|
231 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 102.0
|
151 nanograms per deciliter (ng/dL)
Geometric Coefficient of Variation 519.0
|
Adverse Events
Testosterone Unshaved
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Testosterone Unshaved + Deodorant Spray
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Testosterone Unshaved + Deodorant Antiperspirant Spray
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Testosterone Unshaved + Deodorant Antiperspirant Stick
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Testosterone Shaved
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testosterone Shaved + Deodorant Antiperspirant Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Unshaved
n=29 participants at risk
No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
|
Testosterone Unshaved + Deodorant Spray
n=29 participants at risk
Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Spray
n=29 participants at risk
Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Unshaved + Deodorant Antiperspirant Stick
n=28 participants at risk
Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
Testosterone Shaved
n=26 participants at risk
No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
|
Testosterone Shaved + Deodorant Antiperspirant Spray
n=26 participants at risk
Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
|
|---|---|---|---|---|---|---|
|
General disorders
Nodule
|
0.00%
0/29
|
0.00%
0/29
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Abdominal distension
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/29
|
0.00%
0/29
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Hordeolum
|
0.00%
0/29
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
2/29 • Number of events 2
|
0.00%
0/29
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/29
|
0.00%
0/29
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/26
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
0.00%
0/26
|
0.00%
0/26
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60