UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation effectiveness of YAZ for dysmenorrhea associated with adenomyosis
Title of the study (Brief title)	Effectiveness of YAZ for dysmenorrhea
Region	Japan

Condition
Condition	adenomyosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The investigation effectiveness of YAZ for dysmenorrhea associated with adenomyosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	severity of dysmenorrhoea
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	YAZ
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >
Gender	Female
Key inclusion criteria	The patients of dysmenorrhoea with adenomyosis
Key exclusion criteria	non-pregnant women smoker obesity
Target sample size	25

Research contact person
Name of lead principal investigator	Takeshi Kajihara
Organization	Saitama Medical University
Division name	Department of Obstetrics and Gynecology
Address	Saitama Medical University, 38 Morohongo, Moroyama, Iruma-gun Saitama
TEL	049-276-1347
Email	kajihara@saitama-med.ac.jp

Public contact
Name of contact person	Iino Fumie
Organization	Saitama Medical University
Division name	Clinical trial management center
Address	Saitama Medical University, 38 Morohongo, Moroyama, Iruma-gun Saitama
TEL	049-276-1347
Homepage URL
Email	f_yamamo@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Bayer Yakuhin
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 14 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 14 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017945