738: Topical Alprostadil for the Treatment of Premenopausal Women with Female Sexual Arousal Disorder (FSAD)

Costabile, Raymond A.; McMurray, James G.; Singh, Gita S; Wiatrak, Mitchell; Peterson, Craig A.

doi:10.1016/s0022-5347(18)35970-6

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“…The most recent developments in FSAD have centered on alprostadil (Alista™‐Vivus Inc.) – a prostaglandin E1 agonist. While data are limited, recent results have been presented at the AUA in 2005 in postmenopausal women diagnosed with FSAD (Costabile et al ., 2005). Following a 4‐week nontreatment run‐in period, 51 premenopausal women with a diagnosis of FSAD, as confirmed by medical history, questionnaire assessments, and subject interview, were randomly assigned to treatment with alprostadil 400 mcg and placebo in a double‐blind, crossover‐design study.…”

Section: Female Sexual Dysfunctionmentioning

confidence: 99%

Late‐stage clinical development in lower urogenital targets: sexual dysfunction

Azam

2006

British J Pharmacology

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In recent years, late-stage clinical drug development that primarily focuses on urogenital targets has centered around four areas of medical need (both unmet need and aiming to improve on existing therapies). These include male sexual dysfunction (MSD), female sexual dysfunction (FSD), prostatic pathology (neoplastic, pre-neoplasitic, and non-neoplastic), and improvement in lower urinary tract symptoms. Despite the regulatory approval of compounds to treat erectile dysfunction (ED), benign prostatic hyperplasia, a number of treatments for overactive bladder, and stress urinary incontinence, there remains a deficiency in addressing a number of conditions that arise out of pathophysiological dysfunction resulting in lower urogenital tract sexual conditions. In terms of late-stage clinical development, significant progress has most recently been made in MSD development, especially in understanding further a common and complex sexual dysfunction -that of premature ejaculation. The search also continues for compounds that improve ED in terms of better efficacy and superior safety profile compared to the currently marketed phosphodiesterase-5-inhibitors. Whilst there are no approved medications to treat the subtypes of FSD, there has been significant progress in attempting to better understand how to appropriately assess treatment benefit in clinical trial settings for this difficult to diagnose and treat condition. This review will focus on late-stage human clinical development pertaining to MSD and FSD.

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Section: Female Sexual Dysfunctionmentioning

confidence: 99%

Late‐stage clinical development in lower urogenital targets: sexual dysfunction

Azam

2006

British J Pharmacology

View full text Add to dashboard Cite

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738: Topical Alprostadil for the Treatment of Premenopausal Women with Female Sexual Arousal Disorder (FSAD)

Cited by 1 publication

References 0 publications

Late‐stage clinical development in lower urogenital targets: sexual dysfunction

Late‐stage clinical development in lower urogenital targets: sexual dysfunction

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