Post Marketing Surveillance of MENOPUR | NCT01202123

Studies
Post Marketing Surveillance of MENOPUR

NCT01202123

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Feb 21, 2014Estimated

Enrollment

2,501Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Sep 3, 2010

First Submission Date that Met QC Criteria

Sep 14, 2010

First Posted Date

Sep 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2014

Last Update Posted Date

Feb 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,501Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of follicles per cycle	An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded	Up to 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events	An ART cycle: From ovulation (number and size) to when chemical pregnancy test results are recorded	Up to 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anovulation in women (WHO group II)
Controlled ovarian hyperstimulation cases for ART

Exclusion Criteria:

Hypersensitivity to MENOPUR
Pregnancy, lactation or contraindication to pregnancy
Ovarian cysts not related to polycystic ovarian syndrome
Abnormal uterine bleeding
Tumors in uterus, ovaries and breasts
Ovarian hyperstimulation syndrome
Thromboembolism or history of it
Infertile due to other reason than anovulation
High FSH level indication primary ovarian failure

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Infertile women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Busan Maria hospital		Busan	Busan		South Korea
Daegu Maria

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided