EUCTR2005-004978-25-HU进行中（未招募）不适用
A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptivevaginal ring delivering a daily dose of 150 µg of Nestorone(R) and 15 µg of ethinyl estradiol (150/15 NES/EE CVR)
International Committee for Contraception Research of the Population Council0 个研究点目标入组 2,200 人开始时间: 2006年7月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •a. Healthy women, aged 18-<40 years who wish to use a combined hormonal contraceptive.
- •b. Women not intending to become pregnant for 13 months.
- •c. Intact uterus and both ovaries.
- •d. Prior history of regular menstrual cycles of 28 ± 7 days when not using hormonal contraception; if postpartum or postabortal, history of regular menstrual cycles of 21-35 days in length and at least one cycle (2 menses) with a cycle length consistent with her past cycles.
- •e. Sexually active (currently) and willing to discontinue current contraceptive method to participate in the study.
- •f. In the opinion of the investigator, able to comply with the protocol, e.g. live within the clinic catchment area or within a reasonable distance from the clinic.
- •g. Do not meet any of the exclusion criteria.
- •h. Signed informed consent prior to entry into the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Known hypersensitivity to estrogens or progestins.
- •b. Known hypersensitivity to silicone rubber.
- •c. Known or suspected pregnancy.
- •d. History of infertility of >1.0 year in woman or her male partner.
- •e. History of vasectomy or sterility in male partner.
- •f. Undiagnosed abnormal genital bleeding.
- •g. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. (Subjects diagnosed at screening with a chlamydia or gonococcus infection may be included in the trial following treatment; partner treatment is also recommended. Subjects at high risk for reinfection can be included or excluded per investigator’s discretion.)
- •h. History of pelvic inflammatory disease since last pregnancy episode.
- •i. History of toxic shock syndrome.
- •j. Current abnormal Pap smear (women who have abnormal Pap smears but are ASCUS HPV negative may participate provided there is follow-up for this finding per standard of care).
- •k. Cystoceles or rectoceles or other anatomical abnormality that would preclude use of a vaginal ring.
- •l. Women planning to undergo major surgery.
- •m. Smoking more than 15 cigarettes per day if < 35yrs; any amount of smoking if 35 years and over.
- •n. Breastfeeding.
- •o. Current or past thrombophlebitis or thromboembolic disorders.
- •p. History of venous thrombosis or embolism in a first-degree relative, <55 years of age suggesting familial defect in blood coagulation system
- •q. Cerebrovascular or cardiovascular disease.
- •r. History of retinal vascular lesions, unexplained partial or complete loss of vision.
- •s. Known or suspected carcinoma of the breast.
- •t. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
- •u. Past history of any other carcinoma unless in remission for more than 5 years.
- •v. Current or history of medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
- •w. Headaches with focal neurological symptoms.
- •x. Severe constipation.
- •y. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use.
- •z. Benign or malignant liver tumors; active liver disease.
- •aa. Diastolic blood pressure (BP) >= 85 mm Hg and/or systolic BP >=135 mm Hg after 5-10 min. rest.
- •bb. Known or suspected alcoholism or drug abuse.
- •cc. Abnormal serum chemistry values according to the physician’s judgment.
- •dd. Participation in another clinical trial within last 30 days.
- •ee. Weight >95 kg or >209 lbs.
- •ff. Use of liver enzyme inducers on a regular basis.
- •gg. Use of monthly injectable contraceptives (e.g. cyclofem) unless suspended 2 months before initiation of treatment. Use of Depo-Provera(R) [depo-medroxyprogesterone (DMPA)] unless suspended 6 months before treatment.
- •hh. Current use of implanted hormonal contraceptives, including Mirena(R) [progestin containing intrauterine system (IUS)], Jadelle(R), Norplant(R) or Implanon(R). Subjects using these hormonal products who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
- •ii. Current use of a non-hormonal IUD. Subjects with IUDs who request removal for reasons unrelated to the purpose of enrollment in this study may be considered for participation.
- •jj. Known HIV infection.
- •kk. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. If women enrolled in the study do use condoms to protect against STIs, they should be instructed that th
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