The objective, Dr. Goldfischer stated, was "to determine if efficacy remains with treatment continued for a second 24 weeks of double-blind flibanserin versus placebo in premenopausal women with generalised acquired HSDD who had responded to 24-week, open-label treatment with flibanserin." The researchers also monitored potential withdrawal effects and the safety of flibanserin over the full 48 weeks.

The main initial inclusion criteria specified women 18 years or older who were premenopausal, with a primary diagnosis of generalised acquired HSDD of at least 24 weeks and a Female Sexual Distress Scale-Revised (FSDS-R) score of 15 or greater. Standard related exclusion criteria were also applied.

Following open-label treatment, the enrichment criteria of a 2 or greater increase in satisfying sexual events or 4 or greater desire days/month were set for continuation in this randomised, placebo-controlled phase.

One hundred seventy subjects were randomised to placebo in the continuation part of the trial, while 163 patients continued their flibanserin stable-dosage regimen, as 50 or 100 mg once a day at bedtime or 50 mg twice daily. The baseline characteristics across these 2 treatment groups were similar (respectively) for age (38.4 vs 37.3 years), body mass index (27.5 vs 26.9 kg/m²), marital status (80.6% vs 78.5% married), and duration of current relationship (12.4 vs 11.3 years) and HSDD (63 vs 58 months).

The first coprimary endpoint of mean desire score/month stabilised at 36 weeks at an approximately 4.5 decrease from the randomisation baseline of 34.2. By 32 weeks, this was significantly improved over the placebo group (P < .05), which stabilised later (44 weeks) and lower (approximate 8.5 decrease).

Similarly, for the second coprimary endpoint of mean number of satisfying sexual events/month, there were reductions of approximately 1.5 and approximately 2.5 in the placebo and treatment subjects, respectively, from the randomisation baseline of 7.0. These benefits for flibanserin were significant at 40 (P < .01) and 48 (P < .05) weeks.

The main adverse events during the open-label phase -- somnolence (14.1%), fatigue (10.3%), headache (8.9%), dizziness (8.8%), and nausea (8.0%) -- did not continue into the randomisation phase. In the randomisation phase, flibanserin-treated patients experienced urinary-tract infections (6.1%), sinusitis (4.9%), diarrhoea (3.7%), and nausea (2.5%), although not all occurred more frequently than with placebo.

By the end of this 24-week randomised withdrawal phase of the 48-week ROSE trial, the FSDS-R total score and the Female Sexual Function Index score were also significantly improved over placebo (by 2.9 and 2.1, respectively; P < .05 for both).

In summary, as Dr. Goldfischer confirmed, "Flibanserin continued to be superior to placebo with regard to satisfying sexual events and desire score, as well as sexual functioning."

Funding for this study was provided by Boehringer Ingelheim Pharmaceuticals, Inc.


[Presentation title: Efficacy of Continued Flibanserin Treatment in Premenopausal Women With Hypoactive Sexual Desire Disorder: Results From the ROSE Study. Abstract PD-002]

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