At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 215 enrolled

Drug / intervention

GONAL-f®drug

Likely dose

GONAL-f® 225 IUfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01183143

NCT01183143Phase 3Completed

Compare CT.gov

A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation

Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 17, 2010·Updated Apr 6, 2018

In Brief

A Phase 3 clinical trial evaluating GONAL-f® for Infertility and 2 related conditions. Completed, enrolled 215 participants across 1 site.

Detailed Summary

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfertility, Ovulation Induction, In-Vitro Fertilization

CountriesGermany

Collaborators--

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2004

Primary CompletionMar 2006

First PostedAug 2010

TodayJul 2026

First PostedAug 17, 2010

Enrollment StartMay 11, 2004

Primary CompletionMar 2, 2006

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 15.9 years ago

Interventions

GONAL-f®drug

GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.