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

NCT01607658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2018-08-13

Study results available
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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

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

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Natalia Tkachenko, MD · Trimel Pharmaceuticals Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607658 on ClinicalTrials.gov