A Phase III clinical study to evaluate the efficacy and safety of LF111 4 mg in Japanese women desiring contraception

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 260 人开始时间: 2022年1月31日最近更新: 2024年7月24日

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•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.

•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

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