Efficacy of an Intranasal Testosterone Product

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10.0 mg of TBS-1, 4.0% T.I.D.

TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)

Group Type EXPERIMENTAL

10.0 mg of Testosterone, 4.0% TID

Intervention Type DRUG

13.5 mg of TBS-1, 4.5% B.I.D

TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)

Group Type EXPERIMENTAL

13.5 mg of Testosterone, 4.5% B.I.D

Intervention Type DRUG

11.25 mg of TBS-1, 4.5% T.I.D

TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)

Group Type EXPERIMENTAL

11.25 mg of Testosterone, 4.5% T.I.D

Intervention Type DRUG

Interventions

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10.0 mg of Testosterone, 4.0% TID

Intervention Type DRUG

13.5 mg of Testosterone, 4.5% B.I.D

Intervention Type DRUG

11.25 mg of Testosterone, 4.5% T.I.D

Intervention Type DRUG

Other Intervention Names

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10.0 mg of TBS-1, 4.0% TID 13.5 mg of TBS-1, 4.5% B.I.D 11.25 mg of TBS-1, 4.5% T.I.D

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No