UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009819
Receipt No. R000011508
Scientific Title Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma
Date of disclosure of the study information 2013/01/21
Last modified on 2013/07/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma
Acronym Postoperative recurrence prevention by dienogest treatment in ovarian endometrioma
Scientific Title Effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma
Scientific Title:Acronym Postoperative recurrence prevention by dienogest treatment in ovarian endometrioma
Region
Japan

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

Objectives
Narrative objectives1 The aim of the study is to evaluate the effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is to evaluate the effects of long-term dienogest treatment on postoperative recurrence in ovarian endometrioma.
Key secondary outcomes The secondary outcome is to evaluate the effects of long-term dienogest treatment on postoperative recurrence of pain in ovarian endometrioma.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Medicine: Dienogest
Treatment length:1 year postoperation
Dose: 2 mg per day
Interventions/Control_2 Medicine: no treatment
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
18 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria A person who underwent a conservative surgery for ovarian endometrioma; cystectomy or ablation of ovarian endometrioma.
Key exclusion criteria A person who has allergy for dienogest and who wish to bear children right now.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Takahashi
Organization Yamagata University, Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Iida-nishi 2-2-2, Yamagata
TEL 023-628-5393
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Takahashi
Organization Yamagata University, Faculty of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Iida-nishi 2-2-2, Yamagata
TEL 023-628-5393
Homepage URL
Email totakaha@med.id.yamagata-u.ac.jp

Sponsor
Institute Tohoku Gynecologic Cancer Unit
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
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 山形大学医学部附属病院(山形県)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 21 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 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
2013 Year 01 Month 20 Day
Last modified on
2013 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.