Who is sponsoring NCT01081639?

NCT01081639 is sponsored by Merck KGaA, Darmstadt, Germany.

What condition does NCT01081639 study?

NCT01081639 studies Infertility, Ovulation Induction.

What drugs are being tested in NCT01081639?

Interventions: Follitropin alfa liquid formulation, Follitropin beta liquid formulation.

What is the status of NCT01081639?

NCT01081639 is currently COMPLETED.

Last reviewed 2014-07-30 · How we verify

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

NCT01081639 Phase 3 COMPLETED

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.

Details

Lead sponsor	Merck KGaA, Darmstadt, Germany
Phase	Phase 3
Status	COMPLETED
Enrolment	34
Start date	2003-11
Completion	2004-09

Conditions

Infertility
Ovulation Induction

Interventions

Follitropin alfa liquid formulation
Follitropin beta liquid formulation

Primary outcomes

Convenience and Safety — 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.