Overview

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understanding that consent may be withdrawn by the subject at any time without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