臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 18, 2022
Last modified on	July. 24, 2024
Trial ID	jRCT2031210556

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

Contact for Scientific Queries	Name	Kikuyama Ryoko
	Affiliation	ASKA Pharmaceutical Co., Ltd.
	Address	2-5-1, Shibaura, Minato-ku, Tokyo, Japan
	Telephone	+81-3-5484-8333
	E-mail	aska-clinical@aska-pharma.co.jp
Contact for Public Queries	Name	Kikuyama Ryoko
	Affiliation	ASKA Pharmaceutical Co., Ltd.
	Address	2-5-1, Shibaura, Minato-ku, Tokyo, Japan
	Telephone	+81-3-5484-8333
	E-mail	aska-clinical@aska-pharma.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 01, 2022
Actual date of first enrollment		Jan. 31, 2022
Target sample size		260
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Contraception
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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Overall Pearl Index
Secondary Outcome(s)

Primary Sponsor	ASKA Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5213-0028
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Jan. 07, 2022

Name of Certified Review Board	Japan Conference of Clinical Research Institutional Review Board
Address	1-13-23, Minami-Ikebukuro, Toshima-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-6868-7022
E-Mail	jccr-info@jccr.jp
Approval Status	Approval
Date of approval	Jan. 07, 2022

Name of Certified Review Board	Asai Dermatology Institutional Review Board
Address	1-14, Katabira-cho, Hodogaya-ku, Yokohama-shi, Kanagawa, Japan, Tokyo
Telephone	+81-3-5543-0196
E-Mail	jimukyoku@smo-msr.co.jp
Approval Status	Approval
Date of approval	Jan. 07, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 24, 2024	(this page)	Changes
3	Sept. 23, 2022	Detail	Changes
2	Mar. 18, 2022	Detail	Changes
1	Jan. 18, 2022	Detail

List of change history