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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010332
Receipt No. 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

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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
Obsterics 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
Email

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
Email kahashi@obgy.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Department of Obstetrics and Gynecology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012093

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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