A Study to Evaluate Patient Preference for the Gonal-f Pen Versus Gonadotropins Administered by the Vial and Syringe Method

This study has been completed.

Sponsor:

Information provided by:

EMD Serono

ClinicalTrials.gov Identifier:

NCT00230815

First received: September 29, 2005

Last updated: March 21, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 29, 2005

Last Updated Date

March 21, 2009

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00230815 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Patient Preference for the Gonal-f Pen Versus Gonadotropins Administered by the Vial and Syringe Method

Official Title ^ICMJE

Not Provided

Brief Summary

To evaluate oligoanovulatory infertile women's satisfaction with follitropin alfa injection applied by Pen device compared to their previous experience with injectable gonadotropins. To evaluate the efficacy of follitropin alfa injection applied by Pen device in oligoanovulatory infertile women undergoing ovulation induction who have used injectable gonadotropins previously.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: Gonal-f RFF Pen

Study Arm (s)

Not Provided

Publications *

Somkuti SG, Schertz JC, Moore M, Ferrande L, Kelly E; The Gonal-F Prefilled Pen in OI Study 24785 Group. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006 Oct;22(10):1981-96.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Infertile women
Age 18-40
Oligo-anovulatory infertile women
At least one previous cycle of treatment with injectable gonadotropins

Exclusion Criteria:

Clinically significant systemic disease
Previous treatment with any gonadotropin administered by Pen device in the past six months
Ongoing pregnancy

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00230815

Other Study ID Numbers ^ICMJE

24785

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Eduardo Kelly, MD, MBA

Sponsor GmbH

Information Provided By

EMD Serono

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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