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Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial.
J Sex Med 2011; 8(11):3160-72JS

Abstract

INTRODUCTION

Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD).

AIM

To assess the efficacy and safety of flibanserin over 24 weeks of double-blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open-label treatment with flibanserin.

METHODS

Women (N = 738) were treated with open-label, flexible-dose flibanserin (50 mg or 100 mg/day) for 24 weeks. At week 24, women who showed a predefined response, measured using an eDiary, were randomized to 24 weeks of continued flibanserin therapy at optimized dosage (N = 163) or placebo (N = 170). The criteria for entering the double-blind phase were an increase from baseline to weeks 21-24 of ≥2 satisfying sexual events (SSE) and/or ≥4 "desire days." A "desire day" was one in which a woman reported more than "no" desire.

MAIN OUTCOME MEASURES

Coprimary endpoints were change from randomization to study end in SSE and desire score. Secondary measures included change in Female Sexual Function Index (FSFI) total and desire domain scores and Female Sexual Distress Scale-Revised (FSDS-R) total and Item 13 scores.

RESULTS

During the open-label period, mean SSE and desire score approximately doubled, and FSFI, FSDS-R total, and Item 13 scores improved. At the end of the double-blind period, flibanserin was superior to placebo in change from randomization in SSE, desire score, FSFI desire domain and total scores, and FSDS-R total and Item 13 scores (P < 0.05, for all). Flibanserin was well tolerated, and withdrawal reactions were not observed.

CONCLUSIONS

At the end of the 24-week randomized withdrawal phase of a 48-week trial in premenopausal women with HSDD, flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress. Flibanserin was well tolerated, and no withdrawal reactions were observed following discontinuation.

Authors+Show Affiliations

Hudson Valley Urology, Poughkeepsie, New York, NY 12601, USA. evanrgold@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21933348

Citation

Goldfischer, Evan R., et al. "Continued Efficacy and Safety of Flibanserin in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD): Results From a Randomized Withdrawal Trial." The Journal of Sexual Medicine, vol. 8, no. 11, 2011, pp. 3160-72.
Goldfischer ER, Breaux J, Katz M, et al. Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial. J Sex Med. 2011;8(11):3160-72.
Goldfischer, E. R., Breaux, J., Katz, M., Kaufman, J., Smith, W. B., Kimura, T., ... Pyke, R. (2011). Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial. The Journal of Sexual Medicine, 8(11), pp. 3160-72. doi:10.1111/j.1743-6109.2011.02458.x.
Goldfischer ER, et al. Continued Efficacy and Safety of Flibanserin in Premenopausal Women With Hypoactive Sexual Desire Disorder (HSDD): Results From a Randomized Withdrawal Trial. J Sex Med. 2011;8(11):3160-72. PubMed PMID: 21933348.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Continued efficacy and safety of flibanserin in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD): results from a randomized withdrawal trial. AU - Goldfischer,Evan R, AU - Breaux,Jeffery, AU - Katz,Molly, AU - Kaufman,Joel, AU - Smith,William B, AU - Kimura,Toshio, AU - Sand,Michael, AU - Pyke,Rob, Y1 - 2011/09/20/ PY - 2011/9/22/entrez PY - 2011/9/22/pubmed PY - 2012/3/1/medline SP - 3160 EP - 72 JF - The journal of sexual medicine JO - J Sex Med VL - 8 IS - 11 N2 - INTRODUCTION: Flibanserin is a 5-HT(1A) agonist/5-HT(2A) antagonist that has been shown to increase sexual desire and reduce distress in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD). AIM: To assess the efficacy and safety of flibanserin over 24 weeks of double-blind treatment vs. placebo in premenopausal women with HSDD who showed a predefined response after 24 weeks of open-label treatment with flibanserin. METHODS: Women (N = 738) were treated with open-label, flexible-dose flibanserin (50 mg or 100 mg/day) for 24 weeks. At week 24, women who showed a predefined response, measured using an eDiary, were randomized to 24 weeks of continued flibanserin therapy at optimized dosage (N = 163) or placebo (N = 170). The criteria for entering the double-blind phase were an increase from baseline to weeks 21-24 of ≥2 satisfying sexual events (SSE) and/or ≥4 "desire days." A "desire day" was one in which a woman reported more than "no" desire. MAIN OUTCOME MEASURES: Coprimary endpoints were change from randomization to study end in SSE and desire score. Secondary measures included change in Female Sexual Function Index (FSFI) total and desire domain scores and Female Sexual Distress Scale-Revised (FSDS-R) total and Item 13 scores. RESULTS: During the open-label period, mean SSE and desire score approximately doubled, and FSFI, FSDS-R total, and Item 13 scores improved. At the end of the double-blind period, flibanserin was superior to placebo in change from randomization in SSE, desire score, FSFI desire domain and total scores, and FSDS-R total and Item 13 scores (P < 0.05, for all). Flibanserin was well tolerated, and withdrawal reactions were not observed. CONCLUSIONS: At the end of the 24-week randomized withdrawal phase of a 48-week trial in premenopausal women with HSDD, flibanserin was superior to placebo on measures of SSE, sexual desire, overall sexual function, and sexual distress. Flibanserin was well tolerated, and no withdrawal reactions were observed following discontinuation. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/21933348/Continued_efficacy_and_safety_of_flibanserin_in_premenopausal_women_with_Hypoactive_Sexual_Desire_Disorder__HSDD_:_results_from_a_randomized_withdrawal_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)33306-3 DB - PRIME DP - Unbound Medicine ER -