UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032963 |
|---|---|
| Receipt number | R000037590 |
| Scientific Title | Drug Use-Results Survey of Gonalef (subcutaneous injection) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2018/06/13 09:19:15 |
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Basic information
Public title
Drug Use-Results Survey of Gonalef (subcutaneous injection) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients
Acronym
Drug Use-Results Survey of Gonalef (MHH)
Scientific Title
Drug Use-Results Survey of Gonalef (subcutaneous injection) for Induction of Spermatogenesis in Male Hypogonadotropic Hypogonadism Patients
Scientific Title:Acronym
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 of the Drug Use-Results survey is to collect data on safety and efficacy of Gonalef administered with hCG in adult male hypogonadotropic hypogonadism patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
All patients who were administrated Gonalef 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
| 1st name | |
| Middle name | |
| Last name | Satoshi Kameyama |
Organization
Merck Serono Co., Ltd
Division name
PMS Planning & Strategy, Medical Department
Zip code
Address
Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL
03-6756-0743
satoshi.kameyama@merckgroup.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Suzuka |
Organization
Merck Serono Co., Ltd
Division name
PMS Planning & Strategy, Medical Department
Zip code
Address
Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL
03-6756-0837
Homepage URL
hiroshi.suzuka@merckgroup.com
Sponsor or person
Institute
Merck Serono Co., Ltd.
PMS Planning & Strategy, Medical Department
Institute
Department
Personal name
Funding Source
Organization
Merck Serono Co., Ltd.
PMS Planning & Strategy, Medical Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2005 | Year | 12 | Month | 21 | Day |
Date of IRB
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 |
Other
Other related information
Surveillance following all-case surveillance method
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2018 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037590
