HSDD is a highly prevalent, yet under-diagnosed, medical condition that can have a serious, detrimental effect on women's quality of life, causing significant psychological distress and negatively impacting their relationships with their partners.
HSDD is a type of female sexual dysfunction, defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) of the American Psychiatric Association, as diminished feelings of sexual interest or desire, absent sexual thoughts or fantasies and lack of responsive desire that causes marked distress or interpersonal difficulties and is not caused by a medical condition or drug.(2)
According to renowned sexual health expert, Dr Sheryl Kingsberg, "While sex is an everyday topic of conversation within the media and society as a whole, women's sexual problems are rarely discussed. A decrease in sexual desire has a real and measurable distressing affect on women. The condition impacts almost every aspect of their lives and can become a constant worry." Dr Kingsberg continued, "Both patients and doctors alike are often uncomfortable discussing a woman's sexual concerns but we must encourage women to seek professional advice if they feel distressed because their levels of sexual desire have decreased. We are pleased we can now help facilitate our medical colleagues in the diagnosis of this condition as Boehringer Ingelheim has developed a questionnaire, which allows physicians to reliably identify the many women who are suffering from this distressing condition."
Neurotransmitters in the brain and sex hormones both play a role in normal sexual function.(3) The brain is central to sexual response and while hormonal treatments may be of benefit to some women who suffer from HSDD, for example those women who have had a surgical menopause through ovarectomy (removal of the ovaries), this is by no means the complete answer for the many millions of women experiencing HSDD.
Boehringer Ingelheim is committed to progressing science and contributing to research in this area of unmet medical need through the Bouquet study programme, which consists of seven phase III studies. This programme investigates flibanserin*, a non-hormonal compound as a potential oral daily treatment for pre-menopausal women suffering from HSDD.
"Flibanserin is currently being researched for its potential to help the many women suffering from HSDD. In my everyday practice I have seen many women with this condition for whom this may mean hope as they search for help" said lead study investigator Dr Evan Goldfischer. "Boehringer Ingelheim is setting a great example with its commitment to researching new potential treatment options such as flibanserin. I am hopeful that this will lead to a real breakthrough for this rarely-discussed medical condition".
The results of the Bouquet Studies will be available in late 2008/09. They will represent an important advance in the understanding of this distressing condition and may offer hope for the many millions of women and their partners affected by HSDD.
About The Bouquet Studies
The Boehringer Ingelheim 'Bouquet Study' programme is a group of phase III clinical trials investigating flibanserin* as a potential treatment for women with Hypoactive Sexual Desire Disorder (HSDD), a condition characterised as suffering from decreased sexual desire. Together, the Bouquet Studies aim to demonstrate the efficacy and safety of flibanserin to support regulatory approval of flibanserin* to treat this common and distressing condition.
The Bouquet Studies comprise seven trials including ROSE, DAHLIA, VIOLET, DAISY, ORCHID, SUNFLOWER and MAGNOLIA and are being conducted by Boehringer Ingelheim in North America and Europe involving over 5,000 pre-menopausal women. The trials are expected to be completed in 2008/09.
Endpoints for the trials are based on guidance received from the FDA and include measuring increases in the level of sexual desire, decreases in distress related to low desire, as well as the number of 'satisfying sexual events'. These trials will provide a greater understanding of flibanserin's* potential as a possible oral daily treatment option for woman suffering from decreased sexual desire.