NCT01081639

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
Last Updated

July 31, 2014

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

February 22, 2010

Last Update Submit

July 30, 2014

Conditions

InfertilityOvulation Induction

Keywords

Follitropin alfaFollitropin betaFertilization, in vitroIntracytoplasmic sperm injectionAssisted reproductive techniquesPolycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

  • Convenience and Safety

    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 Outcomes (1)

  • Efficacy

    1 year

Study Arms (2)

Gonal-f

EXPERIMENTAL
Drug: Follitropin alfa liquid formulation

Puregon

ACTIVE COMPARATOR
Drug: Follitropin beta liquid formulation

Interventions

Follitropin alfa liquid formulationDRUG

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

Also known as: Gonal-f
Gonal-f
Follitropin beta liquid formulationDRUG

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

Also known as: Puregon
Puregon

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Porter R, Kissel C, Saunders H, Keck C. Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens. Curr Med Res Opin. 2008 Mar;24(3):727-35. doi: 10.1185/030079908X273291. Epub 2008 Jan 28.

    PMID: 18230195RESULT

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

follitropin alfafollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Study Officials

  • Christoph Keck, PD, Dr. med.

    Universitätsfrauenklinik Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2010

First Posted

March 5, 2010

Study Start

November 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

July 31, 2014

Record last verified: 2010-11