George Washington University and Women's Health & Research Consultants, Washington, DC, USA.
Johns Hopkins University School of Medicine, Baltimore, MD, USA.
J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.
To evaluate the safety of flibanserin in premenopausal and naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) in an open-label extension (OLE) study.
To examine the safety and tolerability of flibanserin 100 mg once daily at bedtime in the treatment of premenopausal and naturally postmenopausal women with HSDD in a multicenter 28-week OLE study.
Patients entering this study received flibanserin or placebo in the double-blinded, placebo-controlled trials of premenopausal and postmenopausal women and in a pharmacokinetic study of postmenopausal women.
The primary end point of this OLE study was the incidence of adverse events (AEs). Secondary exploratory efficacy measures included the Female Sexual Distress Scale-Revised (FSDS-R) total score and FSDS-R item 13 (distress owing to low desire) score and the Female Sexual Function Index (FSFI) total score. Because the sponsor terminated the study early at discontinuation of the development of flibanserin, only descriptive statistics were calculated.
Of the 595 patients receiving study medication, 346 and 249 patients were premenopausal and postmenopausal, respectively. The mean number of days of exposure to flibanserin was 72.8 (SD = 41.6). AEs were reported by 352 patients (59.2%), and most AEs (93.8%) were mild or moderate. The most common AEs (≥5%) were dizziness (9.6%), somnolence (8.6%), insomnia (6.2%), and nausea (5.7%). There were no flibanserin-related serious AEs and no instances of suicidal ideation. The safety profile of flibanserin was similar for premenopausal and postmenopausal women. The FSDS-R total scores and FSDS-R item 13 scores were numerically lower at weeks 4, 12, and 20 than at baseline (decrease in distress owing to low desire) for premenopausal and postmenopausal women. Mean FSFI total scores were numerically higher at weeks 4, 12, and 20 than at baseline, irrespective of menopausal status of the patients.
The results of this study support the safety and tolerability of flibanserin for the treatment of HSDD in premenopausal and naturally postmenopausal women.
Although this open-label study was designed to be 28 weeks long, it was discontinued early by the sponsor, and patients' maximum duration of exposure to flibanserin was 23.9 weeks. The open-label design and lack of a placebo-controlled arm are other study limitations.
In this open-label study, flibanserin 100 mg once daily at bedtime was generally safe and well tolerated by premenopausal and naturally postmenopausal women with HSDD. Simon JA, Derogatis L, Portman D, et al. Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J Sex Med 2018;15:387-395.
评估氟班色林在患有低性欲障碍（HSDD）的绝经前和自然绝经后女性中的安全性，采用开放标签延伸（OLE）研究。
在一项多中心 28 周的 OLE 研究中，评估氟班色林 100mg 每日一次睡前给药治疗绝经前和自然绝经后 HSDD 女性的安全性和耐受性。
进入本研究的患者在绝经前和绝经后女性的双盲、安慰剂对照试验以及绝经后女性的药代动力学研究中接受氟班色林或安慰剂治疗。
OLE 研究的主要终点是不良事件（AE）的发生率。次要探索性疗效指标包括女性性困扰量表修订版（FSDS-R）总分和 FSDS-R 项目 13（因低欲望而困扰）评分以及女性性功能指数（FSFI）总分。由于赞助商在氟班色林研发停止时提前终止了研究，因此仅计算了描述性统计数据。
在这项开放标签研究中，氟班色林 100mg 每日一次睡前给药对患有 HSDD 的绝经前和自然绝经后女性通常是安全且耐受良好的。
