Landmark Clinical Study of Use of Testosterone Patch

Earlier this month, Procter and Gamble announced the results of a safety and efficacy study of treatment with Intrinsa, a female testosterone patch. The study showed increased satisfying sexual activity and desire in patients with Hypoactive Desire Sexual Disorder (lack of sexual desire causing a woman personal distress) who previously had both ovaries removed.

Professor John Rust of The Psychometrics Centre worked with other authors (1) to develop an instrument to measure the outcomes of this study. The Profile of Female Sexual Function (PFSF©) went through a stringent process of development:

• Patients generated a pool of questions which were grouped into wider domains

• The team tested this material to ensure it was valid, reliable and worked in a number of linguistic/cultural environments

• Detailed data collection established the final content and form of the instrument (2)

Professor John Rust commented: "Assessment in clinical, educational, health and work settings is becoming increasingly multinational. The PFSF© was trialled in eight countries (3). It highlighted that even simple questions can have multiple, ambiguous and unintended meanings if they are translated directly from one language to another. Unless these problems are corrected, an instrument may be measuring completely different aspects of human experience in different countries. This has huge implications for the adaptation of assessments for different language groups."

Given the sensitive nature of the measurement and its inclusion in a high profile pharmaceutical trial, the project is a ground-breaking example of cross-cultural assessment development. Final results proved that the PFSF© is a sensitive instrument, discriminating between:

• Low and normal libido in naturally menopausal women
• Surgically menopausal women with low libido and a control group of women with normal libido
• The effects of treatment with a testosterone patch in a clinical trial.

There is also a brief version of the PFSF (B-PSFS) designed to enable women to self-diagnosis and seek advise. 

2th May 2004

(1) The authors of the PFSF© are: J Rust and S Golombok, University of Cambridge, UK; L Derogatis, University of Maryland, Baltimore, USA; J Kuznicki and C Rodenberg, Procter & Gamble Pharmaceuticals, Ohio, USA; and C McHorney, Indiana University School of Medicine, Indianapolis, USA.

(2) The final form of the instrument involved 37 items, grouped in 7 domains: sexual desire; arousal; orgasm; sexual pleasure; sexual concerns; sexual responsiveness; sexual self-image.

(3) PFSF© was validated in 8 countries: France ,Germany ,Holland ,Italy ,the UK ,Canada ,the USA and Australia.