Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2016-04-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LeuplinⓡInj
LeuplinⓡInj(=leuprorelin acetate 3.75mg)
LeuplinⓡInj
Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
CKD-841
CKD-841(=leuprorelin acetate 3.75mg)
CKD-841
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Interventions
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LeuplinⓡInj
Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
CKD-841
Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
Eligibility Criteria
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Inclusion Criteria
* β-hCG is negative at screening and before administration of investigational drug
* Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc...
* Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and \< 25
Exclusion Criteria
* Uncontrolled diabetes mellitus
* Pregnancy or breast feeding
* History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
* Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
* Has abnormal function of liver and kidney at screening
40 Years
65 Years
FEMALE
No
Sponsors
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Severance Hospital
OTHER
Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Min Soo Park, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, South Korea
Countries
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Other Identifiers
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155HPS14022
Identifier Type: -
Identifier Source: org_study_id