A Study to Evaluate Patient Preference for the Gonal-f Pen Versus Gonadotropins Administered by the Vial and Syringe Method
Information source: EMD Serono
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Gonal-f RFF Pen (Drug)
Phase: N/A
Status: Completed
Sponsored by: EMD Serono Official(s) and/or principal investigator(s):
Eduardo Kelly, MD, MBA, Study Director, Affiliation: Sponsor
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.
Clinical Details
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Full FDA approved prescribing information can be found here
Related 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.
Last updated: June 11, 2007
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