Phase III results reignite female sexual dysfunction controversy

A non-hormonal treatment for women with so-called hypoactive sexual desire disorder (HSDD) has completed late-stage clinical testing.

There are currently no treatments approved for hypoactive sexual desire disorder in pre-menopausal women. (Photograph: SPL)
There are currently no treatments approved for hypoactive sexual desire disorder in pre-menopausal women. (Photograph: SPL)

Flibanserin "has the potential to help many women suffering from their lack of sexual desire," according to Professor Rossella Nappi, study investigator and Director of the Gynaecological Endocrinology & Menopause Unit at the Maugeri Foundation, Italy.

However, HSDD remains a controversial concept, with critics arguing that the diagnosis 'medicalises' and oversimplifies the complex issue of female sexuality.

As a 5HT1A agonist, a 5HT2A antagonist, and a partial agonist at dopamine D4 receptors, flibanserin is believed to target pathways in the brain that govern sexual response. It is being developed by Boehringer Ingelheim.

Phase III testing of the drug comprised four randomised, placebo-controlled 24-week trials, of which three (DAISY, VIOLET and DAHLIA) were conducted in North America and one (ORCHID) took place in Europe. All participants were in stable, monogamous, heterosexual relationships.

Pooled analysis of 1,378 women enrolled in the North American DAISY and VIOLET trials showed that flibanserin 100mg daily increased the frequency of satisfying sexual events by 1.7 per month. This improvement was significant compared with the increase of 1 per month obtained with placebo.

There were also significant improvements versus placebo in sexual desire and sexual functioning, and reductions in distress related to sexual dysfunction and low desire.

In the European trial, analysis of data from 634 women revealed improvements versus placebo in sexual desire and reductions in the two distress measures, all of which were significant. However, the increase in satisfying sexual events was not significant compared with placebo.

The adverse effects associated with flibanserin in the trials, including dizziness, nausea, fatigue and insomnia, were generally mild to moderate and transient, but led to discontinuation in approximately 15% of cases.

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases