STUDY OF VAGINAL DANAZOL ON ENDOMETRIOSIS

阴道达那唑治疗子宫内膜异位症的研究

• 批准号: 2716877
• 负责人: JOHN A ZIEMNIAK
• 金额: $ 10万
• 依托单位: FEMME PHARMA, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2000-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2716877
• 关键词: Macaca mulatta; drug administration routes; drug screening /evaluation; endometriosis; estrogen inhibitor; female; nonhuman therapy evaluation; reproductive system disorder chemotherapy; slow release drug

FemmePharma, Inc., a new company devoted to developing products for women, proposes to conduct a feasibility study in monkeys to determine the appropriate dose and safety of a patented, and significant new therapy for endometriosis, a common disease of women with few and unacceptable treatment options. Present treatment options result in significant and unacceptable side effects, often limiting their use to a few months of therapy. Femmepharma's new therapy could create a new and highly effective treatment for this disease with few side effects. The proposed study is a pilot, randomized, ascending-dose, placebo and positive controlled study, in rhesus monkeys (TMcacca mulatta) with endometriosis and will be followed by studies in women. The monkeys will be administered FemmePharma's proprietary treatment and compared to oral danazol. The effect of the proposed treatments on clinical symptoms and behavioral changes suffered by the rhesus monkeys will be recorded and graded throughout the study as primary clinical end points. Secondary end points will include evaluation of endometrial implants, and endometrial biopsies to determine histological changes. Vaginal examination and vaginal smears will be done to record local effects. The study will be conducted in its entirety at the Wisconsin Regional Primate Research Center. PROPOSED COMMERCIAL APPLICATION This may result in a novel method of treatment of women suffering from endometriosis with improved efficacy, and a reduction in side effects. By expanding penetration into the treated population we believe that the commercial value of this to be very significant; revenues greater than 100 million dollars.

FemmePharma, Inc. 是一家致力于开发女性产品的新公司，提议在猴子身上进行一项可行性研究，以确定针对子宫内膜异位症的专利和重要新疗法的适当剂量和安全性，子宫内膜异位症是女性的常见疾病，治疗选择很少且不可接受。 目前的治疗选择会导致显着且不可接受的副作用，通常将其使用限制在几个月的治疗范围内。 Femmepharma 的新疗法可以为这种疾病创造一种新的、高效的治疗方法，而且副作用很少。拟议的研究是一项针对患有子宫内膜异位症的恒河猴（TMcacca mulatta）的试点、随机、剂量递增、安慰剂和阳性对照研究，随后将在女性中进行研究。这些猴子将接受 FemmePharma 的专有治疗，并与口服达那唑进行比较。 拟议治疗对恒河猴临床症状和行为变化的影响将在整个研究过程中作为主要临床终点进行记录和分级。 次要终点包括子宫内膜植入物的评估和子宫内膜活检以确定组织学变化。 将进行阴道检查和阴道涂片以记录局部效果。 该研究将在威斯康星州地区灵长类动物研究中心全面进行。拟议的商业应用这可能会产生一种治疗患有子宫内膜异位症的女性的新方法，该方法具有改善的功效并减少副作用。 通过扩大对治疗人群的渗透，我们相信其商业价值非常重大；收入超过1亿美元。