NCT01607658

Efficacy and Safety of TBS-2 Testosterone Gel in Women With Acquired Female Orgasmic Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Acerus Pharmaceuticals Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Female Orgasmic Disorder

Interventions

Type	Name	Description
DRUG	Placebo	placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
DRUG	Low dose TBS-2	Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
DRUG	Medium dose TBS-2	Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
DRUG	High dose TBS-2	High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-05-30
• Last updated: 2018-08-13
• Results posted: 2018-08-13

Locations

53 sites across 3 countries: United States, Australia, Canada