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Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial.
Menopause 2014; 21(6):633-40M

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+Show Affiliations

From the 1Women's Health and Research Consultants, George Washington University School of Medicine, Washington, DC; 2University Hospitals Case Medical Center, Cleveland, OH; 3Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT; and 4Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24281236

Citation

Simon, James A., et al. "Efficacy and Safety of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the SNOWDROP Trial." Menopause (New York, N.Y.), vol. 21, no. 6, 2014, pp. 633-40.
Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014;21(6):633-40.
Simon, J. A., Kingsberg, S. A., Shumel, B., Hanes, V., Garcia, M., & Sand, M. (2014). Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause (New York, N.Y.), 21(6), pp. 633-40. doi:10.1097/GME.0000000000000134.
Simon JA, et al. Efficacy and Safety of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the SNOWDROP Trial. Menopause. 2014;21(6):633-40. PubMed PMID: 24281236.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. AU - Simon,James A, AU - Kingsberg,Sheryl A, AU - Shumel,Brad, AU - Hanes,Vladimir, AU - Garcia,Miguel,Jr AU - Sand,Michael, PY - 2013/11/28/entrez PY - 2013/11/28/pubmed PY - 2015/2/20/medline SP - 633 EP - 40 JF - Menopause (New York, N.Y.) JO - Menopause VL - 21 IS - 6 N2 - 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. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/24281236/Efficacy_and_safety_of_flibanserin_in_postmenopausal_women_with_hypoactive_sexual_desire_disorder:_results_of_the_SNOWDROP_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=24281236 DB - PRIME DP - Unbound Medicine ER -