背景:目前没有食品和药物管理局批准的女性性唤起障碍(FSAD)的治疗方法,生理上类似于男性勃起功能障碍。
目的:该研究试图测试局部西地那非乳膏的全身和局部生殖器安全性,在12周的治疗期内,患有FSAD的健康绝经前妇女及其性伴侣中占3.6%(西地那非乳膏)。
方法:这是2b阶段,探索性,随机化,安慰剂对照,西地那非乳膏在健康绝经前女性FSAD中的双盲研究。通过参与者及其性伴侣中治疗紧急不良事件(TEAE)的频率和发生率来评估安全性。参与者在每日电子日记(电子日记)中记录TEAE的发生率。在使用研究产品的每个性事件发生后72小时内与性伴侣联系。所有参与者使用安慰剂乳膏1个月,在单盲磨合期,如果符合条件,1:1随机分配给西地那非乳膏或安慰剂乳膏。参与者在12周的双盲给药期内使用他们分配的研究产品。他们参加了每月的随访,研究人员审查了他们的eDiaryTEAE数据,并对其严重程度和与研究产品的关系进行了分级。
结果:参与者及其性伴侣中TEAE的频率和发生率。
结果:在12周的双盲给药期间,西地那非分配给99例参与者中29例报告了78TEAE,安慰剂分配给94例参与者中28例报告了65TEAE(P=.76).所有TEAE的严重程度均为轻度或中度。在活跃和安慰剂分配的参与者中,最常见的与治疗相关的TEAE是应用部位不适。西地那非乳膏与安慰剂乳膏使用者之间治疗相关的TEAE数量没有差异(P>.99)。4名西地那非乳膏参与者和3名安慰剂乳膏参与者由于涉及应用部位不适的TEAE而中断了研究(P>.99)。接触西地那非乳膏的91名性伴侣中有7名报告了9个TEAE,而接触安慰剂乳膏的84名性伴侣中有4名报告了4个TEAE(P=.54)。
结论:这些数据支持西地那非乳膏用于治疗FSAD的进一步临床开发。
在使用西地那非乳膏或安慰剂乳膏的1357和1160次性经历后,对参与者及其性伴侣进行了安全性评估,分别。2b期研究为疗效的主要目标提供了动力,而不是安全。
结论:这些数据表明,局部应用西地那非乳膏是安全的,暴露的使用者及其性伴侣的耐受性良好。
BACKGROUND: There are currently no Food and Drug Administration-approved treatments for female sexual arousal disorder (FSAD), which is physiologically analogous to male erectile dysfunction.
OBJECTIVE: The study sought to test the systemic and local genital safety of topical
sildenafil cream, 3.6% (
sildenafil cream) among healthy premenopausal women with FSAD and their sexual partners over a 12-week treatment period.
METHODS: This was a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream among healthy premenopausal women with FSAD. Safety was assessed by the frequency and incidence of treatment-emergent adverse events (TEAEs) among participants and their sexual partners. Participants recorded the incidence of TEAEs in a daily eDiary (electronic diary). Sexual partners were contacted within 72 hours of each sexual event in which investigational product was used. All participants used placebo cream for 1 month, during a single-blind run-in period, and then if eligible, were randomized 1:1 to sildenafil cream or placebo cream. Participants used their assigned investigational product over a 12-week double-blind dosing period. They attended monthly follow-up visits, in which their eDiary TEAE data were reviewed by the study staff and graded for severity and relationship to study product.
RESULTS: The frequency and incidence of TEAEs among participants and their sexual partners.
RESULTS: During the 12-week double-blind dosing period, there were 78 TEAEs reported by 29 of 99 sildenafil-assigned participants and 65 TEAEs reported by 28 of 94 placebo-assigned participants (P = .76). All TEAEs were mild or moderate in severity. The most common treatment-related TEAE among active and placebo-assigned participants was application site discomfort. There were no differences in the number of treatment-related TEAEs among
sildenafil cream vs placebo cream users (P > .99). Four
sildenafil cream participants and 3 placebo cream participants discontinued the study due to TEAEs involving application site discomfort (P > .99). There were 9 TEAEs reported by 7 of 91 sexual partners exposed to
sildenafil cream vs 4 TEAEs reported by 4 of 84 sexual partners exposed to placebo cream (P = .54).
CONCLUSIONS: These data support further clinical development of topical sildenafil cream for the treatment of FSAD.
UNASSIGNED: Safety was assessed among participants and their sexual partners after 1357 and 1160 sexual experiences in which sildenafil cream or placebo cream were used, respectively. The phase 2b study was powered for the primary objectives of efficacy, rather than safety.
CONCLUSIONS: These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners.