Clinical trial NCT00384046: Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-10-04
Enrollment: 272
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.
timeFrame: Assessment at 12 and 24 weeks
Secondary outcomes:
measure: 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.
timeFrame: Assessment at 12 and 24 weeks
Other outcomes:
Locations:
city: Ashfield
country: Australia
facility: Research Facility
state: New South Wales
city: Gordon
country: Australia
facility: Research Facility
state: New South Wales
city: Randwick
country: Australia
facility: Research Facility
state: New South Wales
city: Dulwich
country: Australia
facility: Research Facility
state: South Australia
city: Prahran
country: Australia
facility: Research Facility
state: Victoria
city: Nedlands
country: Australia
facility: Research Facility
state: Western Australia
city: Freiburg
country: Botswana
facility: Research Facility
state: DEU
city: Montréal
country: Canada
facility: Research Facility
state: Quebec
city: Quebec City
country: Canada
facility: Research Facility
state: Quebec
city: Aachen
country: Germany
facility: Research Facility
city: Hamburg
country: Germany
facility: Research Facility
city: Münster
country: Germany
facility: Research Facility
city: Headington
country: United Kingdom
facility: Site Facility
state: Oxford
city: Solihull
country: United Kingdom
facility: Research Facility
state: West Midlands
city: Atherstone
country: United Kingdom
facility: Research Facility
city: Coventry
country: United Kingdom
facility: Research Facility
city: Doncaster
country: United Kingdom
facility: Research Facility
city: Headington
country: United Kingdom
facility: Research Facility
city: Herts
country: United Kingdom
facility: Research Facility
city: Leicester
country: United Kingdom
facility: Research Facility
city: Leicester
country: United Kingdom
facility: Research Facility
city: Lichfield
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: London
country: United Kingdom
facility: Research Facility
city: Plymouth
country: United Kingdom
facility: Research Facility
city: Salford
country: United Kingdom
facility: Research Facility
city: Warks
country: United Kingdom
facility: Research Facility
Study officials:
affiliation: Procter and Gamble
name: Imran A Lodhi, MD
role: STUDY_DIRECTOR
References: