UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033665 |
|---|---|
| Receipt number | R000038379 |
| Scientific Title | 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 16:15:36 |
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Basic information
Public title
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
Acronym
Special Drug Use-Results Survey of Gonalef (OI)
Scientific Title
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
Scientific Title:Acronym
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
| Obstetrics 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
| 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.
Institute
Department
Personal name
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)
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 | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2009 | Year | 06 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038379
