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: 10079010
• 负责人: KURT BARNHART
• 金额: $ 20.04万
• 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 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10079010
• 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; 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; Time; Transvaginal Ultrasound; United States Food and Drug Administration; Urine; 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; venous thromboembolism

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.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所 （NICHD）的使命是为包括肥胖在内的妇女开发安全有效的避孕药 女性。肥胖是美国人口面临的第一公共卫生问题，是 静脉血栓栓塞（VTE）的独立风险。因此，公共卫生需要 为不增加VTE风险的女性开发有效的避孕。一种食物和 药物管理（FDA） - 批准的避孕方法是仅孕激素的药丸（POP）。 这种方法需要严格遵守每天同时进行流行。该方法 与不规则的出血有关，这通常会导致该方法中断。日常的 低剂量的口服孕酮受体调节剂（PR.WL），例如UPA，已显示为 抑制排卵并引起闭经。内源性雌激素水平不受 PRM。这，该方法将提供一种比流行方案更容易遵循的方案 具有VTE的理论风险较低，尤其是对于肥胖女性。另外，还有体外 有证据表明，A可能保护了活性免受乳腺癌的影响。为了提供 初步证据表明，每天，低剂量A可能有效避孕，临床 试验将在NICHD避孕试验网络（CCTN）中进行。这 提出的研究将依次评估。最初，生殖年龄的妇女正常 月经周期，将接受12周（3天28天）的治疗以评估 这种新避孕药的避孕效率，安全性和可接受性的机制。 受试者将被随机分为3臂： •第1组：每天口服5毫克24天，然后无药间隔为4 天，重复3次。 •第2组：每天口服10毫克，持续84天（12周）而不会中断。 •第3组：UPA 5毫克每天口服84天（12周）而不会中断。