A Phase III clinical study of LF111 in Japanese women desiring contraception

JRCT ID: jRCT2031210556

Registered date:18/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Contraception
• Date of first enrollment: 31/01/2022
• Target sample size: 260
• Study type: Interventional
• Intervention(s): One LF111-4mg tablet will be taken (oral administration) daily for the first 24 days, followed by one LF111-placebo tablet daily for the next 4 days. Administration period will have 13 consecutive cycles, with one cycle defined as 28 days. Extended period will be continued up to Cycle 24.

Outcome(s)

• Primary Outcome: Overall Pearl Index

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

-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.

Exclude criteria

-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

Related Information

• Primary Sponsor: Kikuyama Ryoko