drugset / Trial / NCT01364623
PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 600 ug | Intranasal |
| Subject | Testosterone | Small molecule | 1200 ug | Intranasal |
| Subject | Testosterone | Small molecule | 1800 ug | Intranasal |