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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name