A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating hormone (r-FSH).

Clarification for change of study type:

The study was erroneously registered as an interventional trial on ClinicalTrials.gov between 2010 and 2012. It was shown recently that the study protocol and conduct of the study did not include any clinical interventions beyond those which are Standard Clinical Practice and the approved label for Gonal-f®. Furthermore, all other relevant study essential documentations (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional trial'.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Pre-menopausal female subjects, between their 18th and 39th birthday

• Subjects with body mass index between 18-32 kilogram per square meter (kg/m^2)

• Subjects with FSH (on second day of menstrual cycle) less than 10 milli international unit per milliliter (mIU/ml)

• Subjects who required treatment with recombinant FSH for controlled ovarian hyperstimulation for IVF and/or ICSI

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

• Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice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 are not pregnant or lactating

• Subjects with known allergic reaction against one of the ingredients

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

• Subjects with gynecological bleeding of unknown origin

• Subjects who have ovarian, uterine, or mammary cancer

• Subjects with hyperprolactinemia

• Subjects with tumors of the hypothalamus or the pituitary gland