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

NCT01115725 | Completed

• 1 other identifier: IMP25404
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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'.

Conditions

Infertility

Keywords

Follitropin alfa; Fertilization in vitro; Intracytoplasmic sperm injection; Reproductive techniques, assisted

Outcome Measures

Primary Outcomes (1)

• Convenience assessment

  Subjects' to complete ease questionnaire survey for use of Gonal-f prefilled pens.

  Post-treatment assessment (35-42 days post embryo transfer)

Secondary Outcomes (2)

• Efficacy assessments

  Pre-study (within 3 months prior to study start) to days 35-42 post-hCG

• Safety and tolerance assessments

  First stimulation day (S1) to days 15-20 post-hCG

Study Arms (1)

Gonal-f® prefilled pen

Drug: Gonal-f® (follitropin alfa)

Interventions

Gonal-f® (follitropin alfa) DRUG

Gonal-f® (follitropin alfa) will be given once daily subcutaneously at a starting dose of 150-375 international unit per day (IU/day) by self-administered injection via a pen device for first 5 days. After Day 5, Gonal-f® dose will be adjusted according to the investigator's discretion until ovarian response observed.

Also known as: Recombinant human follicle stimulating hormone (r-hFSH)

Gonal-f® prefilled pen

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

EMBRYOGENESIS IVF Unit

Athens, Kifisias aV, 151 25, Greece

Location

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

follitropin alfa; Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Chorionic Gonadotropin; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Gonadotropins, Pituitary; Luteinizing Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Thyrotropin; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Study Director

  Merck A.E. Hellas, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: November 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 17, 2014

Record last verified: 2012-12

Locations

GR (1)