PER-017-10尚未招募未知
PERICOITAL ORAL CONTRACEPTION WITH LEVONORGESTREL: A PROSPECTIVE, OPEN-LABEL, SINGLE ARM, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY AND ACCEPTABILITY”
FAMILY HEALTH INTERNATIONAL, HPTN CORE,0 个研究点目标入组 0 人开始时间: 2010年8月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 45（—）
- 性别
- Female
入选标准
- •Each woman enrolled in the trial must meet the following inclusion criteria:
- •1. She is competent to provide informed consent to participate in the trial and has done so.
- •2. She is 18 to 45 years old.
- •3. She had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.
- •4. She is at low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:
- •More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months.
- •Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C.
- •Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma.
- •Use of illicit injection drug equipment ever in the past.
- •5. She is willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).
- •6. She wants to avoid pregnancy for at least the next 6.5 months.
- •7. She is willing to accept an uncertain risk of pregnancy during the study.
- •8. She gives correct answers to the informed consent quiz.
- •9. She is willing and able to follow all study requirements.
排除标准
- •To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:
- •1. Pregnant as verified by a pregnancy test at enrollment.
- •2. Has an indication of current subfecundity, specifically:
- •Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy
- •She has not had normal monthly menses for the past 2 months
- • She is currently breastfeeding
- •She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period.
- •Has received an injection of a long term injectable contraceptive in the last 9 months.
- •Currently has an intrauterine device.
- •Has had a sterilization procedure or ectopic pregnancy.
- •Has been diagnosed by a clinician as having a fertility problem.
- •Her partner has had a sterilization procedure or infertility diagnosis, to her knowledge.
- •3. She currently has known contraindications to progestin-only pills, specifically including the following conditions:
- •Unexplained abnormal vaginal bleeding
- •Deep venous thrombosis or pulmonary embolus.
- •Active viral hepatitis.
- •Decompensated cirrhosis.
- •Liver tumor.
- •History of breast cancer.
- •Systemic lupus erythematosus.
- •4. Has a breast mass on examination.
- •5. Has a personal or family history suggestive of predisposition to thrombosis.
- •6. Has a serious contraindication to pregnancy (medical condition or chronic use of medication such as isotretinoin or thalidomide).
- •7. Taking or intends to take drugs that are known to interfere with progestin contraceptive efficacy (such as rifampicin or anticonvulsant medications).
- •8. Has previously participated in this study.
- •9. Currently participating in another medical research study.
- •10. The site investigator or designee perceives another reason to exclude her from the trial.
研究者
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