Healthy ParticipantsPhase 1NCT01725451

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

A Phase 1 study testing Testosterone, Deodorant Spray and Deodorant and Antiperspirant Combination Spray in people with Healthy Participants, run by Eli Lilly and Company at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Testosterone, Deodorant Spray and Deodorant and Antiperspirant Combination Spray
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: Nov 2012to Jan 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 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
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

Other trials in United States

About this study

Official title: Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution

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: Healthy Participants
Being tested: Testosterone, Deodorant Spray, Deodorant and Antiperspirant Combination Spray, Deodorant and Antiperspirant Combination Stick

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug
Also called Axiron, LY900011
Administered topically to axillae
Deodorant SprayOther
Administered topically to axillae
Deodorant and Antiperspirant Combination SprayOther
Administered topically to axillae
Deodorant and Antiperspirant Combination StickOther
Administered topically to axillae

Study groups in NCT01725451
Study group	Role	What they receive
Testosterone Unshaved	Experimental	No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods. Receives: Drug: Testosterone
Testosterone Unshaved + Deodorant Spray	Experimental	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. Receives: Drug: Testosterone; Other: Deodorant Spray
Testosterone Unshaved + Deodorant Antiperspirant Spray	Experimental	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. Receives: Drug: Testosterone; Other: Deodorant and Antiperspirant Combination Spray
Testosterone Unshaved + Deodorant Antiperspirant Stick	Experimental	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. Receives: Drug: Testosterone; Other: Deodorant and Antiperspirant Combination Stick
Testosterone Shaved	Experimental	No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods. Receives: Drug: Testosterone
Testosterone Shaved + Deodorant Antiperspirant Spray	Experimental	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. Receives: Drug: Testosterone; Other: Deodorant and Antiperspirant Combination Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Jan 2013

First posted12 Nov 2012 (estimated)
Study startNov 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01725451
Sponsor's protocol ID: 15083
Other IDs: I5E-MC-TSBD
Status last verified: Oct 2014
First submitted: 8 Nov 2012
Last updated: 16 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution
ClinicalTrials.gov ID: NCT01725451
Acronym / sponsor ID: 15083
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 12 Nov 2012 (estimated)
Results: Posted 3 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Testosterone Unshaved	Experimental	Drug: TestosteroneNo deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.
Testosterone Unshaved + Deodorant Spray	Experimental	Drug: Testosterone, Other: Deodorant SprayDeodorant 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.
Testosterone Unshaved + Deodorant Antiperspirant Spray	Experimental	Drug: Testosterone, Other: Deodorant and Antiperspirant Combination SprayDeodorant 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.
Testosterone Unshaved + Deodorant Antiperspirant Stick	Experimental	Drug: Testosterone, Other: Deodorant and Antiperspirant Combination StickDeodorant 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.
Testosterone Shaved	Experimental	Drug: TestosteroneNo deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.
Testosterone Shaved + Deodorant Antiperspirant Spray	Experimental	Drug: Testosterone, Other: Deodorant and Antiperspirant Combination SprayDeodorant 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.

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TestosteroneAlso: Axiron, LY900011Administered topically to axillae	Drug	Testosterone Shaved, Testosterone Shaved + Deodorant Antiperspirant Spray, Testosterone Unshaved, Testosterone Unshaved + Deodorant Antiperspirant Spray, Testosterone Unshaved + Deodorant Antiperspirant Stick, Testosterone Unshaved + Deodorant Spray
Deodorant SprayAdministered topically to axillae	Other	Testosterone Unshaved + Deodorant Spray
Deodorant and Antiperspirant Combination SprayAdministered topically to axillae	Other	Testosterone Shaved + Deodorant Antiperspirant Spray, Testosterone Unshaved + Deodorant Antiperspirant Spray
Deodorant and Antiperspirant Combination StickAdministered topically to axillae	Other	Testosterone Unshaved + Deodorant Antiperspirant Stick

Primary outcome

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone
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
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.
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone
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
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.

Results and safety

Results posted to the registry on 3 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	8	7
Sequence 2	7	7
Sequence 3	8	8
Sequence 4	7	7

Primary outcome: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone

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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms* hours per deciliter (ng*h/dL)

Measure	Testosterone Unshaved n = 27	Testosterone Unshaved + Deodorant Spray n = 29	Testosterone Unshaved + Deodorant Antiperspirant Spray n = 29	Testosterone Unshaved + Deodorant Antiperspirant Stick n = 28	Testosterone Shaved n = 26	Testosterone Shaved + Deodorant Antiperspirant Spray n = 26
Value	2120 (164.0)	2400 (196.0)	2970 (92.0)	2880 (129.0)	3110 (129.0)	2070 (1733.0)

Population analysed: All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.

Primary outcome: Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone

Measure	Testosterone Unshaved n = 29	Testosterone Unshaved + Deodorant Spray n = 29	Testosterone Unshaved + Deodorant Antiperspirant Spray n = 29	Testosterone Unshaved + Deodorant Antiperspirant Stick n = 28	Testosterone Shaved n = 26	Testosterone Shaved + Deodorant Antiperspirant Spray n = 26
Value	214 (97.0)	209 (119.0)	234 (106.0)	202 (97.0)	231 (102.0)	151 (519.0)

Population analysed: All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone Unshaved	0 of 29 (0%)	3 of 29 (10.3%)	Not reported
Testosterone Unshaved + Deodorant Spray	0 of 29 (0%)	1 of 29 (3.4%)	Not reported
Testosterone Unshaved + Deodorant Antiperspirant Spray	0 of 29 (0%)	2 of 29 (6.9%)	Not reported
Testosterone Unshaved + Deodorant Antiperspirant Stick	0 of 28 (0%)	4 of 28 (14.3%)	Not reported
Testosterone Shaved	0 of 26 (0%)	0 of 26 (0%)	Not reported
Testosterone Shaved + Deodorant Antiperspirant Spray	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25123988Small 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Testosterone, Deodorant Spray and Deodorant and Antiperspirant Combination Spray in people with Healthy Participants, run by Eli Lilly and Company at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725451, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.