CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 253 enrolled
Drug / intervention
Placebo +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/NCT01607658
NCT01607658Phase 2Completed
CompareCT.gov

A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Efficacy and Safety of TBS-2 Intranasal Testosterone Gel in Women With Acquired Female Orgasmic Disorder

Acerus Pharmaceuticals Corporation·interventional·Posted May 30, 2012·Updated Aug 13, 2018

In Brief

A Phase 2 clinical trial evaluating Placebo, Low dose TBS-2, and 2 other interventions for Female Orgasmic Disorder. Completed, enrolled 253 participants across 53 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess and compare the effects of 3 dose strengths of TBS-2 intranasal testosterone gel to placebo on the occurrence of orgasm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFemale Orgasmic Disorder
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2012
Enrollment StartMay 1, 2012
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.1 years ago

Interventions

Placebodrug

placebo intranasal gel administered prn, 2-8 hours before a planned sexual event

Low dose TBS-2drug

Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Medium dose TBS-2drug

Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

High dose TBS-2drug

High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event