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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036913
Receipt No. R000042066
Scientific Title Drug Use-Results Survey of OneCrinone 90 mg Vaginal Gel
Date of disclosure of the study information 2019/06/03
Last modified on 2019/05/31

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Basic information
Public title Drug Use-Results Survey of OneCrinone 90 mg Vaginal Gel
Acronym Drug Use-Results Survey of OneCrinone
Scientific Title Drug Use-Results Survey of OneCrinone 90 mg Vaginal Gel
Scientific Title:Acronym Drug Use-Results Survey of OneCrinone
Region
Japan

Condition
Condition Luteal support as a part of assisted reproductive technology
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of OneCrinone 90 mg Vaginal Gel in the real-world setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of adverse drug reactions and infections, the incidence of serious adverse events, and so on
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients who receive treatment with this product for the approved indication of "Luteal support as a part of assisted reproductive technology" and who have been given informed consent.
Key exclusion criteria Patients with contraindications in the package insert.
Target sample size 430

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Kameyama
Organization Merck Biopharma Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Zip code 153-8926
Address Arco Tower 4F, 8-1, Shimomeguro 1-chome, Meguro-ku, Tokyo, Japan
TEL 03-6756-0743
Email satoshi.kameyama@merckgroup.com

Public contact
Name of contact person
1st name Rieko
Middle name
Last name Takai
Organization Merck Biopharma Co., Ltd
Division name PMS Planning & Strategy, Medical Department
Zip code 153-8926
Address Arco Tower 4F, 8-1, Shimomeguro 1-chome, Meguro-ku, Tokyo, Japan
TEL 03-6756-0857
Homepage URL
Email rieko.takai@merckgroup.com

Sponsor
Institute Merck Biopharma Co., Ltd
Institute
Department

Funding Source
Organization Merck Biopharma Co., Ltd
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 Merck Biopharma Co., Ltd
Address Arco Tower 4F, 8-1, Shimomeguro 1-chome, Meguro-ku, Tokyo, Japan
Tel 03-6756-0857
Email rieko.takai@merckgroup.com

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
2019 Year 06 Month 03 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 486
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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
2017 Year 08 Month 03 Day
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
2019 Year 09 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Drug Use-Results Survey according to the GPSP ordinance

Management information
Registered date
2019 Year 05 Month 31 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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