Ingelheim, Germany (ots/PRNewswire) -
- For Non-US Media
- Boehringer Ingelheim Announces Commitment to Progressing
Science in This Area of Unmet Medical Need With the 'Bouquet'
Data announced at this week's American College of Obstetricians
and Gynecologists (ACOG) annual clinical meeting suggest that up to
one in ten women are suffering from a condition called hypoactive
sexual desire disorder (HSDD) with only a third of these seeking
advice or help from their healthcare professional.(1) 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.(2,3)
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
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
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.
Flibanserin* is an investigational, non-hormonal compound being
studied as a potential oral daily treatment for pre-menopausal women
suffering from Hypoactive Sexual Desire Disorder (HSDD). The compound
works on the central nervous system and acts as a 5-HT1A serotonin
receptor agonist and 5-HT2A serotonin receptor antagonist. Research
is ongoing to provide additional insight into flibanserin's* specific
mechanism of action.
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
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.
For more information please visit
1. Shifren J. Treatment-Seeking Behavior of U.S. Women with
Hypoactive Sexual Desire Disorder (HSDD). Poster presented at The
American College of Obstetricians and Gynecologists 56th Annual
Clinical Meeting in New Orleans on 5 May 2008.
2. Sexual and gender identity disorders. In: American Psychiatric
Association. Diagnostic and Statistical Manual of Mental Disorders.
4th Ed. Washington, DC: American Psychiatric Association;
3. Frank J et al. Diagnosis and Treatment of Female Sexual
Dysfunction. Am Fam Physician 2008;77(5):635-642.
* This compound is an investigational agent. Its safety and
efficacy have not yet been fully established.
ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.ch
James Robertson, +44(0)20-7108-6523, email@example.com