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

NCT01115725 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2014-07-17

No results posted yet for this study

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

Interventions

DRUG

Gonal-f® (follitropin alfa)

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Study Director · Merck A.E. Hellas, an affiliate of Merck KGaA, Darmstadt, Germany

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-06-30
Completion
2008-07-31

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115725 on ClinicalTrials.gov