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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031909
Receipt No. R000036433
Scientific Title Therapeutic Effect of Moxifloxacin versus Azithromycin on Refractory Chronic Endometritis
Date of disclosure of the study information 2018/03/26
Last modified on 2021/09/27

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Basic information
Public title Therapeutic Effect of Moxifloxacin versus Azithromycin on Refractory Chronic Endometritis
Acronym Therapeutic Effect of Moxifloxacin versus Azithromycin on Refractory Chronic Endometritis
Scientific Title Therapeutic Effect of Moxifloxacin versus Azithromycin on Refractory Chronic Endometritis
Scientific Title:Acronym Therapeutic Effect of Moxifloxacin versus Azithromycin on Refractory Chronic Endometritis
Region
Japan

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

Objectives
Narrative objectives1 To compare the therapeutic effect of oral moxifloxacin versus azithromycin on refractory chronic endometritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histopathologic Cure Rate, Clinical Pregnancy Rate, Implantation Rate, Miscarriage Rate, Ongoing Pregnancy Rate
Key secondary outcomes Live Birth Rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral Administration of Moxifloxacin 400mg/day for ten days
Interventions/Control_2 Oral Administration of Azithromycin 500mg/day for three days
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
46 years-old >
Gender Female
Key inclusion criteria Refractory Chronic Endometritis Resistant to Doxycycline and Metronidazole/Ciprofloxacin) Administration
Key exclusion criteria Patients (i) with a history of hypersesitivity to azithromycin, moxifloxacin and/or other new quinolone agents, (ii) with a present illness of severe liver dysfunction, long QT, and/or hypokalemia, (iii) using antiarrhythmic agents, and (iv) having a pregnancy.

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kotaro
Middle name
Last name Kitaya
Organization Reproduction Clinic Osaka
Division name IVF Center
Zip code 5300011
Address Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL 0661363344
Email kitaya@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kotaro
Middle name
Last name Kitaya
Organization Reproduction Clinic Osaka
Division name IVF Center
Zip code 5300011
Address Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL 0661363344
Homepage URL
Email kitaya@koto.kpu-m.ac.jp

Sponsor
Institute Reproduction Clinic Osaka
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Reproduction Clinic Osaka
Address Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel 0661363344
Email sueshita@reposaka.jp

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
2018 Year 03 Month 26 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 26 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
2018 Year 03 Month 26 Day
Last modified on
2021 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036433

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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