Boehringer IngelheimResults from a study published today in the Journal of Sexual Medicine show that a new, easy to use five-question diagnostic tool can significantly reduce the time it takes to diagnose the most common form of female sexual dysfunction (FSD), generalised, acquired Hypoactive Sexual Desire Disorder* (HSDD). Unlike standard diagnostic procedures, which are often time-consuming and require an extensive diagnostic interview by a specially trained clinician, the Decreased Sexual Desire Screener (DSDS) enables clinicians who are not necessarily experts in female sexual dysfunction to diagnose the condition with high accuracy in a few minutes.(1)

Nearly one in 10 women are known to experience low desire marked by distress or interpersonal difficulty - a condition that is medically referred to as Hypoactive Sexual Desire Disorder (HSDD).2 HSDD remains largely under-diagnosed. Physicians and patients are often embarrassed to talk about sexual health. Further reasons healthcare professionals report being reluctant to engage in the discussion include limited time and lack of training.(1) This highlights the increasing need for simple diagnostic instruments that can be used in everyday practice by clinicians who are not specialists or experts in the field of FSD.

According to lead study author Dr Anita Clayton, M.D., Professor of Psychiatry and Neurobehavioral Sciences at the University of Virginia, "Discussing sexual issues, particularly low desire, often can be an uncomfortable conversation for women and health care professionals. This new tool can open up the dialogue, helping physicians and other clinicians to accurately diagnose generalised, acquired HSDD."

The introduction of the DSDS follows the recommendation from the US Food and Drug Administration (FDA) which notes that new diagnostic instruments should be developed and should be able to distinguish patients with FSD, or a specific component of FSD, from those without the disorder.(3)

Consisting of five simple Yes or No questions, the DSDS was specifically developed for use by clinicians not necessarily trained in FSD, to identify generalised acquired HSDD in pre-, peri- and postmenopausal women in a time efficient manner. Diagnostic assessment by DSDS and a standard diagnostic interview, which takes about 45 minutes to complete, were in agreement in 85% of cases. Overall the study validates the DSDS as a quick, efficient and easy to use diagnostic tool in the field of FSD, for women with generalised acquired HSDD.

DSDS Validation Trial Results
The diagnoses made using a standard diagnostic interview and the DSDS agreed in 224 out of 263 cases, indicating that the DSDS had an accuracy of 85.2 percent. In total, 150 participants had a diagnosis of generalised, acquired HSDD by the DSDS, of whom 138 (92 percent) were also diagnosed as having generalised, acquired HSDD by standard diagnostic interview.

  Standard Diagnostic
Interview
DSDS Accuracy
Generalised, acquired HSDD 165 138  
No generalised, acquired HSDD 98 86  
Total number of patients 263 224 85 %

The Questionnaire includes the following questions:

  • In the past, was your level of sexual desire/interest good and satisfying to you?
  • Has there been a decrease in your level of sexual desire/interest?
  • Are you bothered by your decreased level of sexual desire/interest?
  • Would you like your level of sexual desire/interest to increase?

If a woman answers "No" to any of these questions, then she does not qualify for the diagnosis of generalised, acquired HSDD.

In a fifth Yes or No question, women are asked to note any factors from the following list they feel may be contributing to a loss of sexual desire or interest.

  • Medications, drugs or alcohol you are currently taking
  • Pregnancy, recent childbirth, menopausal symptoms
  • Other sexual issues you may be having (pain, decreased arousal or orgasm)
  • Your partner's sexual problems
  • Dissatisfaction with your relationship or partner
  • Stress or fatigue

Answering "No" to all of the factors in question five, would qualify for the diagnosis of generalised, acquired HSDD.

About the DSDS Validation Trial
The prospective, non-treatment study involved 263 women ages 18 to 50 years recruited from 27 centers in the United States and Canada. The study population included women with HSDD, women with other types of FSD, and women with no FSD. None of the participants were receiving any medication or psychological therapy for sexual dysfunction, or any medication that could cause sexual dysfunction or affect the central nervous system. Primary endpoints included the sensitivity and specificity of the DSDS relative to the standard diagnostic interview.

In the study, participants were asked to fill out the DSDS. Then, clinicians who are not specialists or experts in the field of female sexual dysfunction reviewed the responses and determined whether they met the criteria for generalised, acquired HSDD. Subsequently, clinicians who are experts in FSD conducted a standard diagnostic interview with each participant. Results of the interview and those of the DSDS were then compared.

The five DSDS questions were well understood by 85% of subjects included in a debriefing exercise post questionnaire completion. In 93% of cases clinicians not specialised in female sexual dysfunction considered the DSDS questions adequate to diagnose HSDD.

Funding for the study was provided by Boehringer Ingelheim.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion Euros while spending one-fifth of net sales in its largest business segment Prescription Medicines on research and development.

* The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision, defines HSDD as the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity marked by distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications) or a general medical condition. Generalised, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning.

References:
1. Clayton, AH., et al. Validation of the Decreased Sexual Desire Screener (DSDS): A Brief Diagnostic Instrument For Generalized Acquired Female Hypoactive Sexual Desire Disorder (HSDD). J Sex Med 2009; 6(3) 730-738
2. Shifren, JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. Obstet Gynecol 2008; 112(5) 968-9
3. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Draft Guidance for Industry. Female Sexual Dysfunction: Clinical development of drug products for treatment. Rockville, MD, May 2000