Trials / Completed
CompletedNCT01252745
Efficacy of an Intranasal Testosterone Product
An Open Label, Randomized, Balanced, Three Treatment, Parallel Design, Pharmacokinetic Study of Intranasal TBS-1 Administration to Hypogonadal Men
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Acerus Pharmaceuticals Corporation · Industry
- Sex
- Male
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2010-11-01
- Completion
- 2010-12-01
- First posted
- 2010-12-03
- Last updated
- 2018-05-23
- Results posted
- 2018-04-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01252745. Inclusion in this directory is not an endorsement.