Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

April 15, 2013 updated by: Warner Chilcott

24-Week Study to Evaluate the Efficacy/Safety of Transdermal Testosterone in Naturally Menopausal Women With Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen Therapy.

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Ashfield, New South Wales, Australia, 2131
        • Research Facility
      • Gordon, New South Wales, Australia, 2072
        • Research Facility
      • Randwick, New South Wales, Australia, 2031
        • Research Facility
    • South Australia
      • Dulwich, South Australia, Australia, 5065
        • Research Facility
    • Victoria
      • Prahran, Victoria, Australia, 3181
        • Research Facility
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Facility
  • Botswana
    • DEU
      • Freiburg, DEU, Botswana, D-79085
        • Research Facility
  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 1P6
        • Research Facility
      • Quebec City, Quebec, Canada, G1S 2L6
        • Research Facility
  • Germany
      • Aachen, Germany, D-52074
        • Research Facility
      • Hamburg, Germany, 20357
        • Research Facility
      • Münster, Germany, 48149
        • Research Facility
  • United Kingdom
      • Atherstone, United Kingdom, CV9 1EU
        • Research Facility
      • Coventry, United Kingdom, CV7 8LA
        • Research Facility
      • Doncaster, United Kingdom, DN1 2ET
        • Research Facility
      • Headington, United Kingdom, OX3 9DU
        • Research Facility
      • Herts, United Kingdom, SG6 4TS
        • Research Facility
      • Leicester, United Kingdom, LE1 5WW
        • Research Facility
      • Leicester, United Kingdom, LW1 5WW
        • Research Facility
      • Lichfield, United Kingdom, WS14 9LH
        • Research Facility
      • London, United Kingdom, NW8 9NH
        • Research Facility
      • London, United Kingdom, SE1 9RT
        • Research Facility
      • London, United Kingdom, SW1W 8RH
        • Research Facility
      • London, United Kingdom, W12 0HS
        • Research Facility
      • London, United Kingdom, W1G 7JW
        • Research Facility
      • London, United Kingdom, W2 1NY
        • Research Facility
      • Plymouth, United Kingdom, PL4 8QU
        • Research Facility
      • Salford, United Kingdom, M8 8HD
        • Research Facility
      • Warks, United Kingdom, CV9 1EU
        • Research Facility
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • Site Facility
    • West Midlands
      • Solihull, West Midlands, United Kingdom, B91 2JL
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.

Exclusion Criteria:

  • Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo arm
Drug: Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks
Experimental: 1
300mcg/day testosterone
Drug: Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
Time Frame: Assessment at 12 and 24 weeks
Assessment at 12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of the TTS as measured by the following parameters: changes in sexual desire, personal distress, and other domains of PFSF and SAL questionnaires.
Time Frame: Assessment at 12 and 24 weeks
Assessment at 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Imran A Lodhi, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 3, 2006

First Submitted That Met QC Criteria

October 3, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypoactive Sexual Desire Disorder

Clinical Trials on Testosterone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe