To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono GmbH, Germany
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

• Pre-menopausal woman, between her 18th and 39th birthday, receiving recombinant FSH as stimulation for IVF and/or ICSI

• Subjects who were able to communicate well with the investigator and to comply with the requirements of the entire study

• Subjects who had given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice

Exclusion Criteria:

• Subjects who had known allergic reaction against one of the ingredients

• Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)

• Subjects with gynaecological bleeding of unknown origin

• Subjects who had ovarian, uterine, or mammary cancer

• Subjects with tumors of the hypothalamus or the pituitary gland