Hypoactive Sexual Desire Disorder
Conditions
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.
Interventions
DRUGTestosterone
patch, 300 mcg/day testosterone, patch changed every 3-4 days, 24 weeks
DRUGPlacebo
patch, placebo, patch changed every 3-4 days, 24 weeks
Sponsors
Warner Chilcott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | Assessment at 12 and 24 weeks |
Secondary
| 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. | Assessment at 12 and 24 weeks |
Countries
Australia, Botswana, Canada, Germany, United Kingdom
Outcome results
None listed