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

Condition(s) targeted: Hypoactive Sexual Desire Disorder

Intervention: Testosterone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Procter & Gamble Pharmaceuticals

Overall contact:
Carl Eastwood, Email: eastwood.cj@pg.com

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.

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 design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess the efficacy of the TTS by measuring change in frequency of total satisfying episodes. The safety assessment of TTS with various parameters.

Secondary outcome: 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.

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.

Minimum age: 40 Years. Maximum age: 70 Years. Gender(s): Female.

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.

Carl Eastwood, Email: eastwood.cj@pg.com

Research Facility, Freiburg, DEU D-79085, Botswana; Recruiting

Research Facility, Aachen D-52074, Germany; Recruiting

Research Facility, London SE1 9RT, United Kingdom; Recruiting

Research Facility, Atherstone CV9 1EU, United Kingdom; Recruiting

Research Facility, Herts SG6 4TS, United Kingdom; Recruiting

Research Facility, Hamburg 20357, Germany; Recruiting

Research Facility, London NW8 9NH, United Kingdom; Recruiting

Research Facility, Coventry CV7 8LA, United Kingdom; Recruiting

Research Facility, London SW1W 8RH, United Kingdom; Recruiting

Research Facility, Leicester LW1 5WW, United Kingdom; Recruiting

Research Facility, Headington OX3 9DU, United Kingdom; Recruiting

Research Facility, Lichfield WS14 9LH, United Kingdom; Recruiting

Research Facility, London W2 1NY, United Kingdom; Recruiting

Research Facility, London W12 0HS, United Kingdom; Recruiting

Research Facility, Salford M8 8HD, United Kingdom; Recruiting

Research Facility, London W1G 7JW, United Kingdom; Recruiting

Research Facility, Münster 48149, Germany; Recruiting

Research Facility, Leicester LE1 5WW, United Kingdom; Recruiting

Research Facility, Plymouth PL4 8QU, United Kingdom; Recruiting

Research Facility, Doncaster DN1 2ET, United Kingdom; Recruiting

Research Facility, Warks CV9 1EU, United Kingdom; Recruiting

Research Facility, Gordon, New South Wales 2072, Australia; Recruiting

Research Facility, Ashfield, New South Wales 2131, Australia; Recruiting

Research Facility, Randwick, New South Wales 2031, Australia; Recruiting

Site Facility, Headington, Oxford OX3 9DU, United Kingdom; Recruiting

Research Facility, Quebec City, Quebec G1S 2L6, Canada; Recruiting

Research Facility, Montréal, Quebec H1T 1P6, Canada; Recruiting

Research Facility, Dulwich, South Australia 5065, Australia; Recruiting

Research Facility, Prahran, Victoria 3181, Australia; Recruiting

Research Facility, Solihull, West Midlands B91 2JL, United Kingdom; Recruiting

Research Facility, Nedlands, Western Australia 6009, Australia; Recruiting

Starting date: November 2006
Ending date: July 2007
Last updated: March 9, 2007