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

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.

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name