臨床研究等提出・公開システム

Date of registration	July. 20, 2018
Last modified on	Jan. 10, 2020
Trial ID	jRCT2080223983

Scientific Title	Phase II study to evaluate pharmacodynamics, pharmacokinetics and safety after cyclic dose or continuous dose of FSN-013 for 3 cycles in Japanese healthy adult female subjects
Public Title	Phase II study to evaluate pharmacodynamics, pharmacokinetics and safety after cyclic dose or continuous dose of FSN-013 for 3 cycles in Japanese healthy adult female subjects

Completion Date or Terminated date	Sept. 13, 2019
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Fuji pharma Co., Ltd
	Address	5-7 Sanban-cho Chiyoda-ku Tokyo Japan
	Phone Number	+81-3-6862-5566
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Fuji pharma Co., Ltd
	Address	5-7 Sanban-cho Chiyoda-ku Tokyo Japan
	Phone Number	+81-3-6862-5566
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		July. 31, 2018
Target Sample Size		60
Study Type		Interventional
Study Design	Study Design	single center, open, uncontrolled trial
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Japanese Healthy adult female subjects (subjects who were judged to be healthy by investigators) (2) 20 or older and younger than 35 years old (3) Subjects whose weights were 40 kg or more and BMIs were18.5 or more and less than 25.0 at screening examinations (4) Subjects who ovulated between Day9(+/-1) and Day 27(+/-1) of their menstruations in pretreatment observation period and whose progesterone concentrations after that were 5 ng/mL or more and menorrhea didn't start before second registration. (5) Subjects whose both ovaries can be observed by transvaginal ultrasound examinations.
	Exclusion Criteria	(1) Subjects whose menstrual cycles were beyond range of 25 to 38 days regularly (2) Subjects whose spontaneous menorrhea were not observed previously after dosing hormonal products for contraception (3) Subjects in whom unknown cause of abnormal bleedings were observed within past 6 months or their reoccurences were expected during tiral period (4) Subjects whose cervix cytodiagnoses were abnormal previously
	Minimum Age	20age old over
	Maximum Age	34age old under
	Gender	Female
Health Condition or Problem Studied		dysmenorrhea
Intervention(s)		investigational material(s) Generic name etc : FSN-013 INN of investigational material : Estetrol/Drospirenone Therapeutic category code : 248 Mixed hormone preparations Dosage and Administration for Investigational material : oral dose control material(s) Generic name etc : estetrol INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		pharmacodynamics Ovulation inhibition assessed by Hoogland score in 1st and 3rd cycles
Secondary Outcome		safety exploratory pharmacodynamics Blood levels of FSH, LH, endogenous estrogen, endogenous progesterone, thickness of endometrium

Primary Sponsor	Fuji Pharma Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	Fuji Pharma Co., Ltd.
Name of Research Funding	-

Name of IRB	Hakata Clinic Institutional Review Board
Address of IRB	6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 14, 2018

Secondary ID No.	JapicCTI-184041
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Jan. 10, 2020	(this page)	Changes
6	April. 25, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Sept. 05, 2018	Detail	Changes
3	Sept. 05, 2018	Detail	Changes
2	July. 20, 2018	Detail	Changes
1	July. 20, 2018	Detail

List of change history