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

NCT01364623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-10-16

Study results available
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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.

Conditions

  • Female Sexual Dysfunction

Interventions

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

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Natalia Tkachenko, MD · Trimel Pharmaceuticals Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT01364623 on ClinicalTrials.gov