Efficacy of an Intranasal Testosterone Product

Acerus Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypogonadism

Treatments: Drug: 10.0 mg of Testosterone, 4.0% TID; Drug: 13.5 mg of Testosterone, 4.5% B.I.D; Drug: 11.25 mg of Testosterone, 4.5% T.I.D

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252745

TBS-1-2010-01

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

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

Experimental group

Description:

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)

Treatment:

Drug: 10.0 mg of Testosterone, 4.0% TID

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

Experimental group

Description:

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)

Treatment:

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

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

Experimental group

Description:

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)

Treatment:

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