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Sponsored by: |
IBSA Institut Biochimique SA |
Information provided by: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT00335894 |
Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopure, Ferring Pharmaceuticals, Inc.).
Condition | Intervention | Phase |
Infertility |
Drug: hMG-IBSA |
Phase III |
MedlinePlus related topics: | Infertility |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Investigator-Blind, Controlled, Clinical Study of Phase III on the Efficacy and Tolerability of hMG-IBSA (IBSA) Vs Menopure (Ferring) Administered s.c. in Women Undergoing COH in an ART Programme (IVF) |
Estimated Enrollment: | 144 |
Study Start Date: | May 2005 |
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopure, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
Ages Eligible for Study: | 18 Years to 36 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giuseppe De Placido, Prof | 081 74.62.699 ext (+39) |
Italy | |||||
Università degli Studi di Bologna | Recruiting | ||||
Bologna, Italy, 40138 | |||||
Contact: Marco Filicori, Prof. 051 636.76.69 ext +39 | |||||
Principal Investigator: Marco Filicori, Prof | |||||
Università degli Studi di Napoli Federico II | Recruiting | ||||
Napoli, Italy, 80131 | |||||
Contact: Giuseppe De Placido, Prof. 081 74.62.699 ext +39 | |||||
Principal Investigator: Giuseppe De Placido, Prof |
IBSA Institut Biochimique SA |
Study Director: | Giuseppe De Placido, Prof | Federico II University |
Study ID Numbers: | 04I/HMG10 |
First Received: | June 9, 2006 |
Last Updated: | June 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00335894 |
Health Authority: | Italy: The Italian Medicines Agency |
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