Designated Drug Use Investigation 1 of Follistim Injectio... | NCT00920361

Studies
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

NCT00920361

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 4, 2022Actual

Enrollment

1,664Actual

Phase

Not provided

Conditions

Fertilization in Vitro

Interventions

Follitropin beta

Countries

Not provided

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 2022

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

Nov 2005

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jun 12, 2009

First Submission Date that Met QC Criteria

Jun 12, 2009

First Posted Date

Jun 15, 2009Estimated

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 2, 2022

Last Update Posted Date

Feb 4, 2022Actual

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

To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

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

1,664Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients who underwent IVF	Drug: Follitropin beta

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follitropin beta	Drug	Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of retrieved oocytes		2 months, from initiation of treatment to confirmation of pregnancy.

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy outcome		2 months, from initiation of treatment to confirmation of pregnancy.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent IVF

Exclusion Criteria:

Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
Pregnant or possible pregnant women, or lactating women
Patients with undiagnosed atypical vaginal bleeding
Patients with a history of hypersensitivity to any of the ingredients of this product.
Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Japanese 1100 patients

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
C571802	follitropin beta

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided