UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003098
Receipt No. R000003735
Scientific Title Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery
Date of disclosure of the study information 2010/02/01
Last modified on 2010/01/26

* 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 Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery
Acronym Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis
Scientific Title Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery
Scientific Title:Acronym Comparison of the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis
Region
Japan

Condition
Condition the recurrence of endometriosis after laparoscopic surgery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of dienogest with that of low dose oral contraceptive on the recurrence of endometriosis after laparoscopic surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1.During the observation period, the degree of pain will be evaluated by visual analogue scale (VAS) using medical examination by interview
2.During the observation period, the pattern of genital bleeding will be evaluated using medical examination by interview
3.The degree of pain and the degree of genital bleeding during the rest period
will be evaluated using medical examination by interview
Key secondary outcomes In patients with recurrent ovarian chocolate cyst, change in diameter of the ovarian chocolate cyst during the observation period will be evaluated.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One cycle regimen (7 weeks) consists of a consecutive administration of 1 mg of dienogest twice a day for 6 weeks followed by the rest for a week. The cycled regimen will be continued for a year.
Interventions/Control_2 One cycle regimen (7 weeks) consists of a consecutive administration of low dose oral contraceptive for 6 weeks followed by the rest for a week. The cycled regimen will be continued for a year.
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
15 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria Fifty patients with recurrent endometriosis after laparoscopic surgery who met the following inclusion criteria in our facility were enrolled. Written informed consent was obtained from all patients.
1) Patients with histologically proven endometriosis at the first surgical examination
2) Patients without histologically proven adenomyosis at the first surgical examination
3) Patients with recurrent endometriosis related pain, such as dysmenorrhea,
dyspareunia, dyschezia, and the degree of the recurrent pain is the same as that of before surgery.
Key exclusion criteria 1) Patients with undiagnosed genital bleeding
2) Pregnant women or possibly pregnant women
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwaho Kikuchi
Organization Juntendo University faculty of medicine
Division name department of OB/GY
Zip code
Address Hongo 2-1-1 Bunkyo-ku
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University faculty of medicine
Division name department of OB/GY
Zip code
Address
TEL
Homepage URL
Email kikuchiban@hotmail.com

Sponsor
Institute Juntendo University faculty of medicine
department of OB/GY
Institute
Department

Funding Source
Organization Juntendo University faculty of medicine
department of OB/GY
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 02 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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
2010 Year 01 Month 26 Day
Last modified on
2010 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003735

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.