DOXYCYCLINE

强力霉素

• 批准号: 7725339
• 负责人: Bliss E Kaneshiro
• 金额: $ 1.78万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7725339
• 关键词: Adverse effects; Biopsy; Breakthrough Bleeding; Burn injury; Combined Oral Contraceptives; Computer Retrieval of Information on Scientific Projects Database; Contraceptive Agents; Control Groups; Daily; Dose; Double-Blind Method; Doxycycline; Drug Formulations; Endometrial; Enrollment; Funding; Grant; Health Sciences; Hemorrhage; Hormones; Institution; Lead; Methods; Numbers; Oregon; Placebo Control; Placebos; Protocols documentation; Randomized; Research; Research Personnel; Resources; Safety; Schedule; Source; Spottings; Treatment Protocols; United States National Institutes of Health; Universities; Unplanned pregnancy; Upper arm; Woman; antimicrobial; controlled release; day; medical schools; prevent; prospective; satisfaction

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Compared to the traditional cyclic regimen, continuous combined oral contraceptives (COCs) decrease the overall number of scheduled bleeding days (Miller and Hughes, 2003). However, they are associated with irregular bleeding and spotting (Anderson and Hait, 2003). This represents a major nuisance to women and may lead to method discontinuation and unplanned pregnancy. Currently there are no preventative methods or treatment options for unscheduled bleeding associated with continuous COCs. The main objectives in this study are to: (1) determine whether typical dose doxycycline (100 mg BID) taken for five days can be used to decrease the duration of bleeding episodes and (2) determine whether Controlled-Release Sub-antimicrobial (CRSD) doxycycline (40 mg) can prevent bleeding episodes or decrease the number of days of unscheduled bleeding in women using continuous COCs. Secondary objectives are to: (1) document the safety and side effect profile of typical dose doxycycline (100 mg) and CRSD doxycycline when taken with a continuous COC and (2) explore subject satisfaction and compliance with COCs when taken with these doxycycline formulations. We intend to conduct a prospective, randomized, placebo controlled, double blind study at Oregon Health and Science University (OHSU) and John A. Burns School of Medicine (JABSOM). This study will be conducted over four 28-day cycles (112 days of active COC hormone). All women enrolled in the study will take the same daily low dose COC. This protocol is divided into two studies, a bleeding study and an endometrial biopsy study, each with two treatment arms; typical dose doxycycline (Arm 1), and CRSD (Arm 2). Only the bleeding study will be conducted at JABSOM. The first arm (Arm 1) of this study will constitute the typical dose doxycycline arm. In this arm, there will be two study groups. Group 1, the treatment group, will take doxycycline 100 mg orally twice a day for five days starting on the first day of bleeding if breakthrough bleeding occurs. The control group (Group 2) will take a placebo orally twice a day for five days starting on the first day of bleeding if breakthrough bleeding occurs. After three months, both groups will stop doxycycline (or placebo) and will continue on a COC alone for the remaining 28 days of the study. The second arm (Arm 2) of the study will constitute the CRSD doxycycline arm. Subjects in this arm of the study will be divided into Group 3 and Group 4. Group 3 will take CRSD doxycycline (40mg) daily for three months. Group 4 will take a daily placebo. Similarly to the first arm of the trial, after three months, both groups will stop doxycycline (or placebo) and will continue on a COC alone for the remaining 28 days of the study.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，不一定是研究者的机构。 与传统的周期方案相比，连续复方口服避孕药（COC）减少了计划出血天数的总数（Miller 和 Hughes，2003）。 然而，它们与不规则出血和点滴出血有关（Anderson 和 Hait，2003）。 这对女性来说是一个重大麻烦，并可能导致方法终止和意外怀孕。 目前还没有针对与持续 COC 相关的非计划出血的预防方法或治疗方案。 本研究的主要目的是：(1) 确定服用五天的典型剂量多西环素（100 mg BID）是否可用于减少出血发作的持续时间，以及 (2) 确定控释亚抗菌药物 (CRSD) 是否可用于减少出血发作的持续时间。 ) 多西环素（40 毫克）可以预防使用连续 COC 的女性的出血事件或减少意外出血的天数。 次要目标是：(1) 记录典型剂量多西环素 (100 mg) 和 CRSD 多西环素与连续 COC 一起服用时的安全性和副作用特征，以及 (2) 探索受试者在与这些多西环素制剂一起服用时的满意度和对 COC 的依从性。 我们打算在俄勒冈健康与科学大学 (OHSU) 和约翰·伯恩斯医学院 (JABSOM) 进行一项前瞻性、随机、安慰剂对照、双盲研究。 这项研究将进行四个 28 天的周期（活性 COC 激素 112 天）。 所有参与该研究的女性将每天服用相同的低剂量 COC。 该方案分为两项研究，一项出血研究和一项子宫内膜活检研究，每项都有两个治疗组；典型剂量多西环素（第 1 组）和 CRSD（第 2 组）。 JABSOM 仅进行出血研究。 本研究的第一组（Arm 1）将构成典型剂量的多西环素组。 在这个分支中，将有两个研究小组。 第1组，即治疗组，如果发生突破性出血，将从出血第一天开始口服强力霉素100毫克，每天两次，持续五天。 如果发生突破性出血，对照组（第 2 组）将从出血第一天开始，每天口服两次安慰剂，持续五天。 三个月后，两组都将停止使用多西环素（或安慰剂），并在研究的剩余 28 天中继续单独服用 COC。 该研究的第二组（Arm 2）将构成 CRSD 多西环素组。 该研究的受试者将分为第 3 组和第 4 组。第 3 组将每天服用 CRSD 多西环素（40 毫克），持续三个月。 第 4 组每天服用安慰剂。 与试验的第一组类似，三个月后，两组都将停止使用多西环素（或安慰剂），并在研究的剩余 28 天中继续单独服用 COC。