drugset / Trial / NCT01364623

PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women

NCT01364623

Phase 1 Completed 24 enrolled Acerus Pharmaceuticals Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2. In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG and estradiol through pharmacokinetic profiles was also conducted.

Timeline

Start
2011-09
Primary completion
2012-01
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 600 ug Intranasal
Subject Testosterone Small molecule 1200 ug Intranasal
Subject Testosterone Small molecule 1800 ug Intranasal

Indications