Female Sexual Dysfunction Clinical Trial
Official title:
An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels
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.
This is a 2 Period study that requires overnight stays in clinic. Blood samples are required
at all visits including sampling at predefined time periods during the overnight stays.
Period I
Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement
(dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They
remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood
draw and study close-out for those that did not continue with Period II.
Period II (Multi-Dose)
At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing
and able to continue with the multiple-dose portion of the study were selected to participate
in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning
of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
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