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

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384046
• Other study ID #: 2005108
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2006
• Last updated: April 15, 2013
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Testosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
• Placebo
patch, placebo, patch changed every 3-4 days, 24 weeks

Locations

Country	Name	City	State
Australia	Research Facility	Ashfield	New South Wales
Australia	Research Facility	Dulwich	South Australia
Australia	Research Facility	Gordon	New South Wales
Australia	Research Facility	Nedlands	Western Australia
Australia	Research Facility	Prahran	Victoria
Australia	Research Facility	Randwick	New South Wales
Botswana	Research Facility	Freiburg	DEU
Canada	Research Facility	Montréal	Quebec
Canada	Research Facility	Quebec City	Quebec
Germany	Research Facility	Aachen
Germany	Research Facility	Hamburg
Germany	Research Facility	Münster
United Kingdom	Research Facility	Atherstone
United Kingdom	Research Facility	Coventry
United Kingdom	Research Facility	Doncaster
United Kingdom	Research Facility	Headington
United Kingdom	Site Facility	Headington	Oxford
United Kingdom	Research Facility	Herts
United Kingdom	Research Facility	Leicester
United Kingdom	Research Facility	Leicester
United Kingdom	Research Facility	Lichfield
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	London
United Kingdom	Research Facility	Plymouth
United Kingdom	Research Facility	Salford
United Kingdom	Research Facility	Solihull	West Midlands
United Kingdom	Research Facility	Warks

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

Australia,  Botswana,  Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.		Assessment at 12 and 24 weeks	No
Secondary	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.		Assessment at 12 and 24 weeks	No