CCTN - A MULTI-CENTER, RANDOMIZED STUDY TO EVALUATE THE PHARMACOKINETIC AND PHARMACODYNAMIC PROFILE, CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE

CCTN - 一项多中心、随机研究，旨在评估每日口服醋酸乌利司他的药代动力学和药效学特征、避孕功效和安全性

• 批准号: 10005861
• 负责人: KURT BARNHART
• 金额: $ 12.51万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-16 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005861
• 关键词: Acetates; Adherence; Aftercare; Age; Amenorrhea; Attitude; Biopsy; Blood specimen; Cervix Mucus; Chlamydia; Clinic; Clinical; Clinical Chemistry; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive History; Contraceptive methods; Counseling; Data; Dose; Eligibility Determination; Endometrial; Endometrium; Estradiol; Estrogens; Future; Gonorrhea; Guidelines; Gynecology; Height; Hematology; Hemorrhage; In Vitro; Informed Consent; Interruption; Luteal Phase; Measurement; Measures; Medical; Menstrual cycle; Methods; Mission; National Institute of Child Health and Human Development; Non obese; Obesity; Oral; Ovulation; Pap smear; Pattern; Pharmaceutical Preparations; Phase; Physiologic pulse; Population; Positioning Attribute; Pregnancy; Pregnancy Tests; Procedures; Progesterone; Progesterone Receptors; Progestins; Protocols documentation; Public Health; Randomized; Recording of previous events; Recovery; Regimen; Reproductive History; Rest; Risk; Rupture; SHBG gene; Safety; Sampling; Serum; Specific qualifier value; Thick; Thromboembolism; Time; Transvaginal Ultrasound; United States Food and Drug Administration; Urine; Venous; Visit; Weight; Woman; arm; base; birth control; breast exam; contraceptive efficacy; data exchange; demographics; diaries; follow-up; malignant breast neoplasm; pharmacokinetics and pharmacodynamics; pill; recruit; reproductive; screening; side effect; treatment duration

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women, including obese women. Obesity is the number one public health issue facing the US population and is an independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to develop effective contraception for woman that does not increase the risk of VTE. One Food and Drug Administration (FDA)-approved contraceptive method is the progestin-only pill (POP). This method requires strict adherence to taking the POP at the same time every day. The method is associated with irregular bleeding which often leads to discontinuation of the method. Daily low dose oral progesterone receptor modulators (PR.WlS) , such as UPA, have been shown to inhibit ovulation and cause amenorrhea. The endogenous estrogen level is not affected by the PRM. Thus, the method will provide a regimen that is easier to follow than a POP regimen and have a theoretically lower risk of VTE, especially for obese women. In addition, there is in vitro evidence that UP A may have protective activity against breast cancer. In order to provide preliminary evidence that daily, low dose UP A could be effective for contraception, a clinical trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The proposed study will be evaluated sequentially. Initially, women of reproductive age, with normal menstrual cycles, will receive treatment for 12 weeks (three 28-day cycles) in order to evaluate the mechanisms of contraceptive efficacy, safety and acceptability of this new contraceptive. Subjects will be randomized into 3 arms: • Group 1: UP A 5 mg taken orally daily for 24 days followed by a pill-free interval of 4 days, repeated 3 times. • Group 2: UP A 10 mg taken orally daily for 84 days (12 weeks) without interruption. • Group 3: UPA 5 mg taken orally daily for 84 days (12 weeks) without interruption.

尤妮斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所 （NICHD）的使命是为妇女，包括肥胖妇女，开发安全有效的避孕药具。 妇女肥胖是美国人口面临的头号公共健康问题， 静脉血栓栓塞（VTE）的独立风险。因此，公共卫生需要 为女性开发有效的避孕措施，不会增加VTE的风险。一种食物和 美国药物管理局（FDA）批准的避孕方法是孕激素避孕药（POP）。 这种方法需要严格遵守每天在同一时间服用POP。述的方法 与不规则出血有关，这通常导致该方法的中断。每日 低剂量口服孕酮受体调节剂（PR、WS），如UPA，已经显示出， 抑制排卵并引起闭经。内源性雌激素水平不受 PRM.因此，该方法将提供比POP方案更容易遵循的方案， 从理论上讲，患静脉血栓栓塞的风险较低，尤其是肥胖女性。此外，在体外 有证据表明UP A可能对乳腺癌有保护作用。以此为您提供 初步证据表明，每日低剂量的UPA可能对避孕有效，这是一种临床研究。 试验将在NICHD避孕临床试验网络（CCTN）中进行。的 将按顺序对拟议研究进行评价。最初，育龄妇女，正常 月经周期，将接受12周（3个28天周期）的治疗，以评估 避孕效果、安全性和可接受性的机制。 受试者将随机分为3组： ·第1组：每天口服服用UP A 5mg，持续24天，随后无药丸间隔4天 天，重复3次。 ·第2组：每天口服UP A 10 mg，持续84天（12周），不间断。 ·第3组：每天口服UPA 5mg，持续84天（12周），不间断。