Dysmenorrhea
Conditions
Interventions
One tablet (LPRI-CF113-4mg or LF111-4mg) will be administrated once daily for the first 24 days, followed by one tablet (LPRI-CF113-2.8mg or LF111-placebo) administrated once daily for the next 4 days
Sponsors
Imaizumi Emi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Capable of understanding the details of the study and can provide written voluntary consent to participate in the study -Healthy premenopausal Japanese female aged >=18 years and =40 kg and BMI >=18.5 kg/m2 and <=25.0 kg/m2 at screening tests -Normal menstrual cycle and menstrual period -Ovulation in PRE-TREATMENT cycle and the endocrine test results meeting the criteria -Both ovaries can be observed by transvaginal ultrasound examinations
Exclusion criteria
Exclusion criteria: -Current or previous diseases considered unsuitable for this study, such as liver disorders, renal disorders, cerebral cardiovascular disorders, gastrointestinal disorders, hematological disorders, endocrine disorders and .gynecological disorders -Allergic predisposition to a drug or food -Alcohol dependence or history of alcohol dependence -Positive pregnancy test at the screening tests -Pregnant (childbirth, miscarriage or abortion) or breastfed within 3 months before obtaining informed consent -Positive drug abuse test result at the screening tests -Positive for HBs antigen, HCV antibody, HIV antigen/antibody, HTLV-1 antibody, or serologic test for syphilis at the screening tests -At least 200 mL or 400 mL of blood has been donated within 4 or 16 weeks before receiving the investigational product, respectively, or blood components have been donated within 2 weeks before receiving the investigational product -Participated in another clinical study in which an investigational product was received within 16 weeks (or within 12 weeks for an approved investigational product) prior to dosing of the investigational product or participating -Need prohibited drugs -undiagnosed abnormal uterine bleeding -Person who is deemed by the investigator to be unsuitable as a participant in this study because of tests of screening and PRE-TREATMENT cycle
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hoogland Score, Serum E2, P4, LH, FSH concentration, Follicle Size, Endometrial Thickness, Uterine Bleeding | — |
Contacts
Public ContactEmi Imaizumi
ASKA Pharmaceutical Co., Ltd.
Outcome results
None listed