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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033659
Receipt No. R000038373
Official scientific title of the study Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients
Title of the study (Brief title) Special Drug Use-Results Survey of Gonalef (MHH)
Region
Japan

Condition
Condition Male Hypogonadotropic Hypogonadism
Classification by specialty
Endocrinology and Metabolism Pediatrics Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to collect data on safety and effectiveness of Gonalef administered with hCG over a year (up to 4 years) in adult male hypogonadotropic hypogonadism patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes (Safety)
1. Adverse events
1-1. Frequency and severity of adverse events
1-2. The relationship between adverse events and dose, dosage form or manufacturing method (serum-free)
Key secondary outcomes (Safety)
1. Changing of body weight
1-1. Descriptive statistics of observed values and change from baseline are summarized in a table or a figure.
(Effectiveness)
1. Spermatogenesis
1-1. The percentage of the patients who show spermatogenesis and its 95% CI are presented.
1-2. Descriptive statistics of the time to spermatogenesis from start of concomitant therapy are presented.
1-3. Background factors that may have influence on efficacy (spermatogenesis) are analyzed by multivariate analysis.
2. Other effectiveness endpoints
(Serum testosterone level, Tanner stage (pubic hair and penis), Capacity of testis)
2-1. Descriptive statistics of observed values and change from baseline are summarized
3. Pregnancy of the partner

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Participating patients of Drug Use-Results Survey of Gonalef (MHH)
2. All patients who were administrated Gonalef up to 1 year for patient with male hypogonadotropic hypogonadism (MHH), the indication of this Drug Use-Results Survey, including idiopathic, secondary and genetic MHH.
Key exclusion criteria Patients who do not give a full consent to this survey.
Target sample size 300

Research contact person
Name of lead principal investigator Satoshi Kameyama
Organization Merck Serono Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Address Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0743
Email satoshi.kameyama@merckgroup.com

Public contact
Name of contact person Hiroshi Suzuka
Organization Merck Serono Co., Ltd.
Division name PMS Planning & Strategy, Medical Department
Address Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL 03-6756-0837
Homepage URL
Email hiroshi.suzuka@merckgroup.com

Sponsor
Institute Merck Serono Co., Ltd.
Institute
Department

Funding Source
Organization Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 12 Month 21 Day
Anticipated trial start date
2006 Year 06 Month 20 Day
Last follow-up date
2016 Year 01 Month 22 Day
Date of closure to data entry
2016 Year 01 Month 22 Day
Date trial data considered complete
2016 Year 03 Month 18 Day
Date analysis concluded
2016 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
Other related information Surveillance following all-case surveillance method

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038373

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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