CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Low dose testosterone nasal gel, single dose +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01364623
NCT01364623Phase 1Completed
CompareCT.gov

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

Acerus Pharmaceuticals Corporation·interventional·Posted Jun 2, 2011·Updated Oct 16, 2019

In Brief

A Phase 1 clinical trial evaluating Low dose testosterone nasal gel, single dose, Medium dose testosterone nasal gel, single dose, and 2 other interventions for Female Sexual Dysfunction. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemale Sexual Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2011
Enrollment StartSep 1, 2011
Primary CompletionJan 1, 2012
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.1 years ago

Interventions

Low dose testosterone nasal gel, single dosedrug

Low dose testosterone nasal gel, single dose

Medium dose testosterone nasal gel, single dosedrug

Medium dose testosterone nasal gel, single dose

High dose testosterone nasal gel, single dosedrug

High dose testosterone nasal gel, single dose

Medium dose testosterone nasal gel, multiple dosedrug

Medium dose testosterone nasal gel, multiple dose