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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033665
Receipt No. R000038379
Official scientific title of the study Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome 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 Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome Patients
Title of the study (Brief title) Special Drug Use-Results Survey of Gonalef (OI)
Region
Japan

Condition
Condition Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome (OI)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to collect the occurrence of adverse events and demographic factors affecting safety in clinical practice of Gonalef administered in ovulation induction in patients with anovulation or oligo-ovulation accompanying hypothalamic-pituitary dysfunction or polycystic ovary syndrome patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes (Safety)
1-1. Adverse drug reactions and infections (term, severity, incidence, etc.)
1-2. Factors related to safety (term and incidence of adverse drug reactions, etc. by patient background)
Key secondary outcomes (Effectiveness)
1-1. Factors related to effectiveness (ovulation rate by patient background)
1-2. Pregnancy Rate
1-3. Course of Pregnant/Postpartum Women and Delivered Children

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 Female
Key inclusion criteria Among patients who were administrated Gonalef for patient with ovulation induction in patients with anovulation or oligo-ovulation accompanying hypothalamic-pituitary dysfunction or polycystic ovary syndrome (OI), mothers whose pregnancy was confirmed and their babies in the Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for patient with OI.
Key exclusion criteria Patients who do not give a full consent to this survey.
Target sample size 90

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
2009 Year 06 Month 17 Day
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
2013 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 05 Month 12 Day
Date analysis concluded
2015 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
Other related information Surveillance following central registration method
As target sample size, it collected 50 cases as births follow-up.

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=R000038379

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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