UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003098 |
|---|---|
| Receipt number | 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 22:06:36 |
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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
| Obstetrics 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
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
kikuchiban@hotmail.com
Sponsor or person
Institute
Juntendo University faculty of medicine
department of OB/GY
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003735
