UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015432
Receipt number R000017945
Scientific Title The investigation effectiveness of YAZ for dysmenorrhea associated with adenomyosis
Date of disclosure of the study information 2014/10/14
Last modified on 2018/10/18 07:28:59

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Basic information

Public title

The investigation effectiveness of YAZ for dysmenorrhea associated with adenomyosis

Acronym

Effectiveness of YAZ for dysmenorrhea

Scientific Title

The investigation effectiveness of YAZ for dysmenorrhea associated with adenomyosis

Scientific Title:Acronym

Effectiveness of YAZ for dysmenorrhea

Region

Japan


Condition

Condition

adenomyosis

Classification by specialty

Obstetrics 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

1st name
Middle name
Last name Takeshi Kajihara

Organization

Saitama Medical University

Division name

Department of Obstetrics and Gynecology

Zip code


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

1st name
Middle name
Last name Iino Fumie

Organization

Saitama Medical University

Division name

Clinical trial management center

Zip code


Address

Saitama Medical University, 38 Morohongo, Moroyama, Iruma-gun Saitama

TEL

049-276-1347

Homepage URL


Email

f_yamamo@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 10 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017945


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name