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Efficacy of an Intranasal Testosterone Product | Clinical Trials | Clareo Health

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COMPLETEDPhase 2NCT01252745

Efficacy of an Intranasal Testosterone Product

This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism

Lead sponsor: Acerus Pharmaceuticals Corporation•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Acerus Pharmaceuticals Corporation

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels \>100 ng/dl and ≤ 300 ng/dL.
•Normal Otolaryngological nasal endoscopy examination.
•Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

Exclusion Criteria

•Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones
•Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months
•History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery.
•History of nasal disorders (e.g. polyposis, recurrent epistaxis ( \> 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 23, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment22

Start dateAug 2010

Last updatedMay 23, 2018

Condition

Locations shown

Quality of Life Medical and Research Center

Tucson, Arizona

Pharmax Research Clinic Inc.

Miami, Florida

Regional Urology LLC

Shreveport, Louisiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions