JPRN-jRCT2071200065
Completed
Phase 1
Phase I/II study to investigate the pharmacokinetics, safety, and hormonal concentrations after single and multiple doses of LF111 (drospirenone) in healthy Japanese women
Kikuyama Ryoko0 sites12 target enrollmentDecember 16, 2020
ConditionsContraception
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- Kikuyama Ryoko
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy premenopausal Japanese women aged 20 years or older and 35 years or younger at the time of informed consent.
- •\-Non\-smokers (those who have not smoked within 6 months before obtaining informed consent).
- •\-Individuals who have a normal menstrual cycle (25 days to 38 days) including the menstrual period (bleeding from 3 days to 7 days) more than once before obtaining informed consent.
- •\-Individuals who agree on appropriate contraceptive methods other than oral contraceptives and intrauterine luteal hormone release system, including partners throughout the study.
Exclusion Criteria
- •\-Individuals who have a positive pregnancy test at the time of screening.
- •\-Individuals who are pregnant (childbirth, miscarriage or abortion) or breastfed within 3 months before obtaining informed consent.
- •\-A cervical smear (cytology) at screening that was determined to be positive (other than negative (NILM) by Bethesda System 2014\).
- •\-Individuals who currently have or have a history of thrombophlebitis, venous or arterial thromboembolic disease (thrombosis, pulmonary embolism, cerebral infarction, myocardial infarction).
- •\-Individuals with severe nervous system disease, digestive system disease, liver disease, or a problem taking the study drug.
- •\-Individuals assessed by the investigator as having clinically significant abnormalities in labolatory test at screening.
- •\-Individuals with renal or adrenal insufficiency or hepatic impairment.
- •\-Individuals with a history of intolerance to oral contraceptives.
- •\-Individuals who are or suspected of alcoholism, drug addiction.
- •\-Individuals who participated in another clinical trial within 16 weeks before administration of the investigational drug and received the investigational drug or who are currently participating in another clinical trial.
Outcomes
Primary Outcomes
Not specified
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