NCT01364623

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

An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Female Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	Low dose testosterone nasal gel, single dose	Low dose testosterone nasal gel, single dose
DRUG	Medium dose testosterone nasal gel, single dose	Medium dose testosterone nasal gel, single dose
DRUG	High dose testosterone nasal gel, single dose	High dose testosterone nasal gel, single dose
DRUG	Medium dose testosterone nasal gel, multiple dose	Medium dose testosterone nasal gel, multiple dose

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-01-01
• Completion: 2012-02-01
• First posted: 2011-06-02
• Last updated: 2019-10-16
• Results posted: 2019-09-13

Locations

1 site across 1 country: United States