Intrarosa（prasterone，又名脱氢表雄酮[DHEA]）产品。首个获批每日使用一次，治疗绝经后女性性生活疼痛 Intrarosa是被美国FDA批准第一个含有活性成分普拉斯通（prasterone，又名脱氢表雄酮[DHEA]）产品，每日使用一次，适用于更年期女性因雌激素水平下降引起外阴和阴道萎缩导致性生活过程中出现中度至重度性交疼痛的治疗。 FDA药品评价和研究中心(CDER)内药物评价III骨，生殖，和泌尿系统产品(DBRUP)部副主任Gassman，M.D.说："性交期间疼痛是绝经后妇女报告VVA的最常见症状之一，Intrarosa 为寻求缓解VVA所致性交疼痛妇女提供附加治疗选择。" 批准日期：2016年11月 17日；公司：Endoceutics Inc INTRAROSA™(普拉雄酮 prasterone)阴道插入剂 美国初次批准：2016 作用机制 普拉雄酮是一种无活性内源性甾体和被转化至活性雄激素和/或雌激素。INTRAROSA在有外阴和阴道萎缩绝经后妇女的作用机制未完全地确定。 适应证和用途 INTRAROSA™是一种甾体适用为中度至严重性交疼痛的治疗，一种由于绝经外阴和阴道萎缩的症状。 剂量和给药方法 一次阴道插入，在睡时每天1次。 剂型和规格 阴道插入：6.5mg的普拉雄酮。 禁忌证 未诊断异常生殖器出血. 警告和注意事项 乳癌的当前或过去史。 不良反应 在四项12-周随机化，安慰剂-对照临床试验，最常见不良反应有一个发生率 ≥2%为阴道排出物。 在一项52-周开放临床试验，最常见不良反应有一个发生率≥2%是阴道排出物和异常Pap涂片。 供应/贮存和处置 供应 INTRAROSA以白色至灰白色1.3mL硬脂子弹-形状，光滑阴道插入(含6.5mg的普拉雄酮)供应。可得到在在小盒中有4个透明塑料罩每个含7个阴道插入包装的INTRAROSA(28个阴道插入每盒)。小盒(含阴道插入)是在含28个阴道插入应用器[applicators]的一个较大盒内供应(NDC 69110-001-01)。 贮存和处置 贮存在41°F至86°F(5°C至30°C)。可被贮存在室温或在冰箱内。 Intrarosa (prasterone intravaginal) General Information Intrarosa (prasterone) is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of Intrarosa in postmenopausal women with vulvar and vaginal atrophy is not fully established. Intrarosa is specifically indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa is supplied as a vaginal insert. Administer one Intrarosa vaginal insert once daily at bedtime, using the provided applicator. Clinical Results FDA Approval The FDA approval of Intrarosa for moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause was based on two primary 12-week placebo-controlled efficacy trials. The trials enrolled 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. The women were randomly assigned to receive Intrarosa or a placebo vaginal insert. All subjects were assessed for improvement from Baseline to Week 12 for four co-primary efficacy endpoints: most bothersome moderate to severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginal pH. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse. Side Effects Adverse effects associated with the use of Intrarosa may include, but are not limited to, the following: vaginal discharge abnormal Pap smear Mechanism of Action Intrarosa (prasterone) is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of Intrarosa in postmenopausal women with vulvar and vaginal atrophy is not fully established.