CompletedNCT01725451Updated Oct 16, 2014Results posted

A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants

A Phase 1 interventional study of Testosterone and Deodorant Spray in Healthy Participants, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-16.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 50 Years and older
Sex: Male

Study summary

This study will evaluate the effect of deodorant and antiperspirant use and the presence of underarm hair on the absorption of testosterone. Each participant in this study will receive 6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm. There is a minimum one day washout period between each dose. This study will last approximately 24 days not including screening. Screening is required within 30 days prior to the start of the study.

Conditions studied

Healthy Participants

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Are overtly healthy males, as determined by medical history and physical examination
Agree to use a reliable method of birth control (for example, condom or vasectomy) during the study and for 1 month following the last dose of testosterone
Have a total testosterone level \<400 nanograms per deciliter (ng/dL) based on local laboratory result
Have a hemoglobin ≥12 grams per deciliter (g/dL) at screening and, if the participant takes a break from the study, at the re-test
Weigh at least 60 kilograms (kg)
Have venous access sufficient to allow for blood sampling
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Have given written informed consent approved by Eli Lilly and Company (Lilly) and the ethical review board (ERB) governing the site

Exclusion criteria

Exclusion Criteria:

Use any topical testosterone replacement therapy within the 2 weeks prior to randomization through the last dosing period, except for use of testosterone solution as directed by study procedures
Use parenteral testosterone replacement (testosterone enanthanate, testosterone cypionate) within the 30 days prior to screening. Use long-acting intramuscular testosterone undecanoate 6 months prior to screening, or use of testosterone pellets 12 months prior to screening
Have a body mass index >35 kilograms per square meter (kg/m\^2)
Have a significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone
Currently use any medications, herbal, and/or nutritional supplements that can interfere with testosterone
Have a dermatologic condition in the underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy
Have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders constituting a risk when taking the study medication of that could interfere with the interpretation of the data
Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Have an abnormal prostate-specific antigen (PSA) test result
Have known allergies to testosterone solution, related compounds or any components of the formulation, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure as determined by the investigator
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of human immunodeficiency (HIV) infection and/or positive human HIV antibodies
Are participants who have previously completed or withdrawn from this study or any other study investigating testosterone
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Have shaved the axillae within 3 months of screening

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 30 participants (actual)

Study arms

Experimental
Testosterone Unshaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.
Drug: Testosterone
Experimental
Testosterone Unshaved + Deodorant Spray
Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
Drug: Testosterone · Other: Deodorant Spray
Experimental
Testosterone Unshaved + Deodorant Antiperspirant Spray
Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
Drug: Testosterone · Other: Deodorant and Antiperspirant Combination Spray
Experimental
Testosterone Unshaved + Deodorant Antiperspirant Stick
Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
Drug: Testosterone · Other: Deodorant and Antiperspirant Combination Stick
Experimental
Testosterone Shaved
No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.
Drug: Testosterone
Experimental
Testosterone Shaved + Deodorant Antiperspirant Spray
Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.
Drug: Testosterone · Other: Deodorant and Antiperspirant Combination Spray

Interventions

DrugTestosterone
Administered topically to axillae
Also known as: Axiron, LY900011
OtherDeodorant Spray
Administered topically to axillae
OtherDeodorant and Antiperspirant Combination Spray
Administered topically to axillae
OtherDeodorant and Antiperspirant Combination Stick
Administered topically to axillae

What researchers measure

Primary outcomes

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
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.
Time frame: 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
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
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.
Time frame: 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 Mar 3, 2014

Participant flow

Period 1

Participant flow — Period 1
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	8	7	8	7
Completed	7	7	8	7
Not completed	1	0	0	0
Withdrew: Withdrawal by subject	1	0	0	0

Washout From Period 1

Participant flow — Washout From Period 1
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	7	8	7
Completed	7	7	8	7
Not completed	0	0	0	0

Period 2

Participant flow — Period 2
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	7	8	7
Completed	7	7	8	7
Not completed	0	0	0	0

Washout From Period 2

Participant flow — Washout From Period 2
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	7	8	7
Completed	7	7	8	7
Not completed	0	0	0	0

Period 3

Participant flow — Period 3
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	7	8	7
Completed	7	7	8	7
Not completed	0	0	0	0

Washout From Period 3

Participant flow — Washout From Period 3
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	7	8	7
Completed	7	6	7	7
Not completed	0	1	1	0
Withdrew: Protocol violation	0	0	1	0
Withdrew: Adverse event	0	1	0	0

Period 4

Participant flow — Period 4
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	6	7	7
Completed	7	6	6	7
Not completed	0	0	1	0
Withdrew: Adverse event	0	0	1	0

Washout From Period 4

Participant flow — Washout From Period 4
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	6	6	7
Completed	7	6	6	7
Not completed	0	0	0	0

Period 5

Participant flow — Period 5
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	6	6	7
Completed	7	6	6	7
Not completed	0	0	0	0

Washout From Period 5

Participant flow — Washout From Period 5
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	6	6	7
Completed	7	6	6	7
Not completed	0	0	0	0

Period 6

Participant flow — Period 6
Milestone	Sequence 1	Sequence 2	Sequence 3	Sequence 4
Started	7	6	6	7
Completed	7	6	6	7
Not completed	0	0	0	0

Outcome measures

PrimaryPharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone

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.

Time frame:: 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
Reported as:: Geometric mean · nanograms* hours per deciliter (ng*h/dL)

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
nanograms* hours per deciliter (ng*h/dL)	Testosterone Unshaved	Testosterone Unshaved + Deodorant Spray	Testosterone Unshaved + Deodorant Antiperspirant Spray	Testosterone Unshaved + Deodorant Antiperspirant Stick	Testosterone Shaved	Testosterone Shaved + Deodorant Antiperspirant Spray
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone	2120 ± 164.0	2400 ± 196.0	2970 ± 92.0	2880 ± 129.0	3110 ± 129.0	2070 ± 1733.0

PrimaryPharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone

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.

Time frame:: 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
Reported as:: Geometric mean · nanograms per deciliter (ng/dL)

Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
nanograms per deciliter (ng/dL)	Testosterone Unshaved	Testosterone Unshaved + Deodorant Spray	Testosterone Unshaved + Deodorant Antiperspirant Spray	Testosterone Unshaved + Deodorant Antiperspirant Stick	Testosterone Shaved	Testosterone Shaved + Deodorant Antiperspirant Spray
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone	214 ± 97.0	209 ± 119.0	234 ± 106.0	202 ± 97.0	231 ± 102.0	151 ± 519.0

Adverse events

Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Testosterone Unshaved	—	0/29 (0%)	3/29 (10.3%)
Testosterone Unshaved + Deodorant Spray	—	0/29 (0%)	1/29 (3.4%)
Testosterone Unshaved + Deodorant Antiperspirant Spray	—	0/29 (0%)	2/29 (6.9%)
Testosterone Unshaved + Deodorant Antiperspirant Stick	—	0/28 (0%)	4/28 (14.3%)
Testosterone Shaved	—	0/26 (0%)	0/26 (0%)
Testosterone Shaved + Deodorant Antiperspirant Spray	—	0/26 (0%)	0/26 (0%)

Most frequent other events

Most frequent other events
Event	Testosterone Unshaved	Testosterone Unshaved + Deodorant Spray	Testosterone Unshaved + Deodorant Antiperspirant Spray	Testosterone Unshaved + Deodorant Antiperspirant Stick	Testosterone Shaved	Testosterone Shaved + Deodorant Antiperspirant Spray
Upper respiratory tract infectionInfections and infestations	2/29	0/29	0/29	1/28	0/26	0/26
ToothacheGastrointestinal disorders	0/29	0/29	0/29	1/28	0/26	0/26
NoduleGeneral disorders	0/29	0/29	0/29	1/28	0/26	0/26
Back painMusculoskeletal and connective tissue disorders	1/29	0/29	0/29	1/28	0/26	0/26
Muscle spasmsMusculoskeletal and connective tissue disorders	0/29	0/29	0/29	1/28	0/26	0/26
Abdominal distensionGastrointestinal disorders	1/29	0/29	0/29	0/28	0/26	0/26
HordeolumInfections and infestations	0/29	0/29	1/29	0/28	0/26	0/26
HeadacheNervous system disorders	1/29	0/29	0/29	0/28	0/26	0/26
ParaesthesiaNervous system disorders	0/29	1/29	1/29	0/28	0/26	0/26

Baseline characteristics

All randomized participants who received at least 1 dose of testosterone 2% solution.

Age, Continuous
Age, Continuous(years)	Testosterone 2% Solution
Mean	59.7 ± 7.9

Sex: Female, Male
Sex: Female, Male(Participants)	Testosterone 2% Solution
Female	0
Male	30

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Testosterone 2% Solution
American Indian or Alaska Native/White	1
Black or African American	1
White	28

Region of Enrollment
Region of Enrollment(participants)	Testosterone 2% Solution
United States	30

Screening Testosterone
Screening Testosterone(nanograms per deciliter (ng/dL))	Testosterone 2% Solution
Mean	290.8 ± 78.2

Study locations

2 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daytona Beach, Florida 32117, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Evansville, Indiana 47710, United States

References and documents

Publications

Small DS, Ni X, Polzer P, Vart R, Satonin DK, Mitchell MI. Effect of deodorant and antiperspirant use and presence or absence of axillary hair on absorption of testosterone 2% solution applied to men's axillae. J Sex Med. 2014 Nov;11(11):2809-17. doi: 10.1111/jsm.12658. Epub 2014 Aug 14. PubMed 25123988 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01725451
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Nov 12, 2012
Start date: Nov 2012
Primary completion: Jan 2013
Completion: Jan 2013
Results posted: Mar 3, 2014
Last update: Oct 16, 2014

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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