Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial.

Abstract

OBJECTIVE:

This study aimed to assess the efficacy and safety of flibanserin, a serotonin receptor 1A agonist/serotonin receptor 2A antagonist, in postmenopausal women with hypoactive sexual desire disorder (HSDD).

METHODS:

Naturally postmenopausal women with HSDD received flibanserin 100 mg once daily at bedtime (n = 468) or placebo (n = 481) for 24 weeks. Co-primary endpoints were changes from baseline to week 24 in the number of satisfying sexual events (SSEs) across 28 days and in the Female Sexual Function Index (FSFI) desire domain score. Secondary endpoints included change from baseline in Female Sexual Distress Scale-Revised (FSDS-R) Item 13 score (which assesses distress due to low sexual desire), FSDS-R total score, and FSFI total score. The Patient Benefit Evaluation was asked on treatment discontinuation.

RESULTS:

There were significant improvements with flibanserin versus placebo in the mean (SE) changes in the number of SSEs (1.0 [0.1] vs 0.6 [0.1]), FSFI desire domain score (0.7 [0.1] vs 0.4 [0.1]), FSDS-R Item 13 score (-0.8 [0.1] vs -0.6 [0.1]), FSDS-R total score (-8.3 [0.6] vs -6.3 [0.6]), and FSFI total score (4.2 [0.4] vs 2.7 [0.4]; all P < 0.01). More women on flibanserin (37.6%) than women on placebo (28.0%) reported experiencing meaningful benefits from the study medication on treatment discontinuation. The most frequent adverse events associated with flibanserin were dizziness, somnolence, nausea, and headache.

CONCLUSIONS:

In naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire, improvement in the number of SSEs, and reduced distress associated with low sexual desire, and is well tolerated.

• Authors: James A Simon, Sheryl A Kingsberg, Brad Shumel, Vladimir Hanes, Miguel Garcia Jr, Michael Sand
• Journal: Menopause (New York, N.Y.) (Menopause) Vol. 21 Issue 6 Pg. 633-40 (Jun 2014) ISSN: 1530-0374 [Electronic] United States
• PMID: 24281236 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzimidazoles
• Serotonin Receptor Agonists
• flibanserin

Topics

• Adult
• Aged
• Benzimidazoles (adverse effects, therapeutic use)
• Disorders of Excessive Somnolence (chemically induced)
• Dizziness (chemically induced)
• Double-Blind Method
• Female
• Headache (chemically induced)
• Humans
• Middle Aged
• Nausea (chemically induced)
• Postmenopause
• Serotonin Receptor Agonists (adverse effects, therapeutic use)
• Sexual Dysfunctions, Psychological (drug therapy)
• Sexuality (drug effects)
• Surveys and Questionnaires