JPRN-jRCT2031210556进行中（未招募）3 期
A Phase III clinical study to evaluate the efficacy and safety of LF111 4 mg in Japanese women desiring contraception
Kikuyama Ryoko0 个研究点目标入组 260 人开始时间: 2022年1月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Premenopausal Japanese women of childbearing potential aged >=20 years at the time of informed consent
- •-Desire to use oral contraception continuously for 13 cycles
- •-Meet one of the following:
- •a. If the subject is not using a combined oral contraceptive (COC), intrauterine device (IUD), or intrauterine system (IUS) at the time of informed consent, she must be confirmed to have had at least 4 normal menstrual cycles with normal duration of menstruation during 6 months before informed consent.
- •b. If the subject is using a COC, IUD, or IUS at the time of informed consent, she must be confirmed to have had normal menstrual cycles with normal duration of menstruation before starting the use of COC, IUD, or IUS.
- •c. If the subject had delivery, abortion, or stillbirth within the past 6 months before informed consent, she must be confirmed to have had at least one normal menstrual cycle with normal duration of menstruation after the delivery, abortion, or stillbirth.
排除标准
- •-Pregnant women or women desiring to become pregnant during the study period
- •-Having a history or current condition of the following:
- •a. Ovulation disorder such as polycystic ovary syndrome
- •b. Infertility
- •c. Unexplained abnormal uterine bleeding
- •d. Active venous thromboembolism
- •e. History of severe liver disease or unresolved laboratory abnormalities
- •f. Severe or acute renal failure
- •g. Malignant tumor within 5 years before informed consent
- •h. Lactose intolerance
- •i. Allergy to any ingredients of the investigational product
- •j. Alcohol dependence or drug dependence within 6 months before informed consent
- •k. Disease being treated (or under consideration of treatment) that precludes participation in this study in the opinion of the investigator
- •-Having screening test results meeting any of the following:
- •a. Pregnancy confirmed by a positive pregnancy test
- •b. Resting systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg
- •c. AST or ALT level >3 times the upper limit of normal (ULN)
- •d. Obvious abnormalities in laboratory tests (except for those judged to be physiological variations and placed under follow-up)
- •e. Positive cervical cytology result
- •f. Abnormalities on transvaginal ultrasonography or breast examination precluding study participation
- •g. Positive test result for sexually transmitted disease
研究者
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