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

July 30, 2014 updated by: Merck KGaA, Darmstadt, Germany

Phase III Study on the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Formulation Applied by a Pen Versus Follitropin Beta Liquid Formulation Applied by Pen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI) currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.

Recently, a new formulation of follitropin alfa has been developed due to a general trend in the field of therapeutic recombinant proteins to move from presentations based on biological activity to presentations based on physico-chemical characteristics. Until now follitropin alfa has been produced as a powder for injection (either as monodose or multidose preparations) in glass ampoules or in glass vials and administered using plastic or glass syringe. Serono developed a multidose solution for injection in a prefilled disposable injection pen. This study involved comparing the administration of follitropin alfa liquid formulation applied by pen with that of follitropin beta liquid formulation also applied by pen.

OBJECTIVES The objectives of this study were to evaluate the convenience, safety and efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon) liquid pen.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gonal-f
Drug: Follitropin alfa liquid formulation
Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Names:
  • Gonal-f
Active Comparator: Puregon
Drug: Follitropin beta liquid formulation
Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other Names:
  • Puregon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Convenience and Safety
Time Frame: 1 year

Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period.

Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 1 year
Collection of routine data from the RecDate registry such as: stimulation duration; FSH starting dose; FSH dosage on last treatment day; total amount of gonadotrophin needed; number of follicles on the day of the last ultra-scan; number of oocytes retrieved; number of fertilized oocytes; number of embryos transferred; wastage of product; number of cartridges of Gonal-f (300 IU, 450 IU, and 900 IU) and Puregon (300 IU and 600 IU) opened; clinical pregnancy by Ultra-scan (if already available at time point of final report writing).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono GmbH, Germany

Investigators

  • Principal Investigator: Christoph Keck, PD, Dr. med., Universitätsfrauenklinik Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (Estimate)

March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMP 24554

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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