Effect of Continuous vs. Sequential Oral Contraception

描述（由申请人提供）：在传统OCP方案的安慰剂期间发生的戒断性出血是不必要的和不希望的，并且有助于大幅度的方法停药率。美国女性是世界上意外怀孕率最高的国家之一。在本提案中，我们将通过随机双盲试验验证长期（6个月）连续联合口服避孕药（CCOCP）方案（20杯乙炔雌二醇/1毫克醋酸去甲稀酮）比传统的21天活性避孕药/7天安慰剂OCP方案（21/ 70cp）产生更深远的子宫内膜和卵巢抑制作用的假设。目前，临床医生通常将CCOCP用于各种适应症，但其安全性和有效性的数据很少。作为子宫内膜和卵巢活动的临床标志，我们将使用出血天数作为本研究的主要结局。我们将通过超声监测子宫内膜厚度和卵巢卵泡形成，通过活检监测子宫内膜组织学，通过每月血清和每日尿液测量卵巢类固醇产生，以及通过问卷调查监测患者满意度。我们认为，减少cocp方案的出血天数将提高患者对该避孕方案的满意度和依从性。我们推测，长期的cococp方案可能更有效地抑制卵巢卵泡发育和子宫内膜生长，因为在安慰剂期间，由于抑制作用的丧失，激素水平的反弹较少。因此，这种方案既可以提供有效的避孕（有更大的余地跳过药片），也可以更有效地治疗多种妇科疾病，如痛经、功能失调性子宫出血、子宫内膜异位症和周围雄激素紊乱，如痤疮和多毛症，还可以更大程度地降低子宫内膜癌和卵巢癌的风险。因此，cococp方案的风险和益处是一个重要的妇女健康问题，值得调查。

DESCRIPTION (provided by applicant): Withdrawal bleeding that occurs during the placebo period of the traditional OCP regimen is unnecessary and unwanted, and contributes to substantial method discontinuation rates. In U.S. women this contributes to one of the highest unwanted pregnancy rates in the world. In this proposal we will test the hypothesis that a long-term (6 month) continuous combined oral contraceptive pill (CCOCP) regimen (20 mug ethinyl estradiol/1 mg norethindrone acetate) will result in more profound endometrial and ovarian suppression than a traditional 21 day active pill/7 day placebo OCP regimen (21/70CP) with a randomized double blind trial. Currently CCOCP is commonly used by clinicians for a variety of indications, with little data of its safety and efficacy. As the clinical marker of endometrial and ovarian activity, we will be using number of bleeding days as the primary outcome in this study. We will secondarily monitor endometrial thickness and ovarian follicle formation by ultrasound, endometrial histology by biopsy, ovarian steroid production by monthly serum and daily urinary measurements, and patient satisfaction by questionnaire. We believe that a reduction in days of bleeding that will occur on a CCOCP regimen will improve patient satisfaction and compliance with this contraceptive regimen. We theorize that a tong-term CCOCP regimen may more effectively suppress ovarian follicular development and endometrial growth, because there are fewer rebounds in hormone levels due to loss of suppression during placebo periods. This regimen may therefore provide both effective contraception (with greater leeway for skipped pills) as well as more effective treatment of multiple gynecological conditions such as dysmenorrhea, dysfunctional uterine bleeding, endometriosis, and peripheral androgen disorders such as acne and hirsutism, as well as a greater reduction in risk for endometrial and ovarian cancer. Therefore, the risks and benefits of a CCOCP regimen are an important women's health issue that warrant investigation.