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FDA批准Intrarosa用于治疗绝经后女性性交疼痛

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

发布者:FDA 发布时间:2016-11-30

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

美国FDA批准了Intrarosa(prasterone,普拉睾酮)用于治疗女性中至重度性交疼痛,这是由于绝经而出现的一种外阴和阴道萎缩症状。Intrarosa是FDA批准的首个含有普拉睾酮(又称脱氢表雄酮)活性成分的产品。

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

女性在绝经期,阴道组织雌激素水平下降,可导致外阴和阴道萎缩,引起性交疼痛等症状。

"Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women," said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). "Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA."

FDA药品评价与研究中心(CDER)药品评价三室骨骼生殖泌尿系统产品部(DBRUP)副主任Audrey Gassman博士指出:性交疼痛是绝经后女性报告最常见的外阴和阴道萎缩症状之一,对于寻求缓解外阴和阴道萎缩导致性交疼痛的女性,Intrarosa提供了另一种治疗选择。

Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 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. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

Intrarosa是一种每日一次的阴道植入剂,其有效性在2项为期12周的安慰剂对照临床试验中得到证实。这2项试验纳入406例40~80岁健康的绝经后女性,她们认为中至重度性交疼痛是外阴和阴道萎缩最恼人的症状。与安慰剂相比,Intrarosa可减轻性交疼痛的严重程度。

The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Intrarosa的安全性在4项为期12周的安慰剂对照试验和1项为期52周的开放标签试验中得到证实。最常见的不良反应为阴道分泌物和宫颈涂片检查结果异常。

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.

尽管DHEA已用于某些膳食补充剂中,但这些产品用于诊断、纠正、缓解、治疗或预防任何疾病的有效性和安全性尚未确定。

Intrarosa is marketed by Quebec-based Endoceutics Inc.

Intrarosa由位于魁北克省的Endoceutics公司上市销售。

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来源: FDA

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