UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010332 |
|---|---|
| Receipt number | R000012093 |
| Scientific Title | A Randomized Parallel Group Controlled Study between 3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2013/03/27 19:11:45 |
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Basic information
Public title
A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis
Acronym
A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis
Scientific Title
A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis
Scientific Title:Acronym
A Randomized Parallel Group Controlled Study between
3.75 mg of Leuprorelin and 1.8 mg of Goserelin Depot in the Sequential Therapy (GnRH Agonist + Dienogest) for Treatment of Endometriosis
Region
| Japan |
Condition
Condition
endometriosis, chocolate cyst or adenomyosis uteri
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endometriosis, chocolate cyst and adenomyosis uteri are the diseases recurring repeatedly, and long-term therapeutic plan is required for treatment. In this study, the efficacy and safety of sequential therapy with GnRH agonist shall be compared for the purpose of long-term treatment in the female patients weighing 50 kg or more, who were diagnosed as endometriosis, chocolate cyst and adenomyosis uteri, and the efficacy and safety shall be compared among GnRH agonists.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Incidence of genital bleeding in 12 to 36 weeks after start of study (0 to 24 weeks after administration of dienogest)
Key secondary outcomes
The changes in the following items before and after treatment should be compared among 3 groups:
1. Improvement rate of subjective symptoms according to the VAS score
2. Reduction rate of the thickness of endometrium determined by the transvaginal ultrasonography before, 12 and 36 weeks after treatment
3. Reduction rate of the diameter of ovarian chocolate cyst determined by the transvaginal ultrasonography before, 12 and 36 weeks after treatment
4. Hormone kinetics, CA125 and other laboratory test values
5. Bone density and bone metabolism marker
6. Incidence of adverse reaction and discontinuation rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Leuprorelin + dienogest treatment group (Group L):
Leuprorelin acetate should be administered subcutaneously once 4 weeks (28 days) at a dose of 3.75 mg for 12 weeks (initial administration should be performed during menstruation), and dienogest should be administered orally at a daily dose of 2 mg in two divided doses for 24 weeks without establishing the withdrawal period. (Total period of administration: 36 weeks)
Interventions/Control_2
2. Goserelin + dienogest treatment group (Group G):
Goserelin acetate should be administered subcutaneously once 4 weeks (28 days) at a dose of 1.8 mg for 12 weeks (initial administration should be performed during menstruation), and dienogest should be administered orally at a daily dose of 2 mg in two divided dose for 24 weeks without establishing the withdrawal period. (Total period of administration: 36 weeks)
Interventions/Control_3
3. Dienogest treatment group (Group D):
Dienogest should be administered orally at a daily dose of 2 mg in two divided doses for 36 weeks (initial administration should be performed during menstruation).
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Patients aged 20 years or older and weighing 50 kg or more at acquisition of consent
2. Patients diagnosed as endometriosis, chocolate cyst or adenomyosis uteri
3. Patients with ovulatory menstruation
4. Patients who received sufficient explanation before participation in this study, understood it and gave written consent based on the free will of the patient oneself
Key exclusion criteria
1. Patients with undiagnosed abnormal genital bleeding
2. Pregnant or possibly pregnant women
3. Lactating patients
4. Patients with a past history of hypersensitivity to GnRH agonists or dienogest
5. Patients treated with hormone drugs (oral contraceptive, danazol, GnRH agonists, etc.) and dienogest within the past 4 months
6. Other patients considered ineligible as subjects by investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Matsui |
Organization
Tokyo Women's Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
8-1Kawada-cho,Shinjuku-ku,Tokyo,JAPAN
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hashimoto |
Organization
Tokyo Women's Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
8-1Kawada-cho,Shinjuku-ku,Tokyo,JAPAN
TEL
03-3353-8111
Homepage URL
kahashi@obgy.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
none
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
東京女子医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 28 | 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
| 2012 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 28 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012093
