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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000026073 |
Receipt No. | R000029900 |
Scientific Title | Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma |
Date of disclosure of the study information | 2017/02/13 |
Last modified on | 2017/02/09 |
Basic information | ||
Public title | Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma
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Acronym | Goserelin trial | |
Scientific Title | Randomized trial of clinical effect of 6 months or 3months Gn-RH agonist (Goserelin acetate 1.8mg) to endometriosis comlicated uterine myoma
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Scientific Title:Acronym | Goserelin trial | |
Region |
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Condition | ||
Condition | Endometriosis, myoma | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To ascess the optimal administration frequency of goserelin acetate for patients with endometriosis complicated uterine myoma. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Change of diameter of uterine myoma (measured by MRI) before and after administration |
Key secondary outcomes | Changes of VAS score
Chages of serum FSH, LH and estradil |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Dose comparison |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | NO |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | goserelin acetate injection 3 times every 4 weeks | |
Interventions/Control_2 | goserelin acetate injection 6 times every 4 weeks | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | patients with endometriosis and uterine myoma
premenopausal women |
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Key exclusion criteria | pregnant patient
severe clinical complication (ex.cancer) patients who were desired for emergent operation unknown genital bleeding |
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Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Nara Medical University | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 840, Shijo-cho, Kashihara, Nara, JAPAN | ||||||
TEL | 0744-22-3051 | ||||||
syoshida1208@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Nara Medical University | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | |||||||
Address | 840, Shijo-cho, Kashihara, Nara, JAPAN | ||||||
TEL | 0744-22-3051 | ||||||
Homepage URL | |||||||
syoshida1208@gmail.com |
Sponsor | |
Institute | Department of Obstetrics and Gynecology
Nara Medical University |
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 | |
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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 |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029900 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |