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NCT00329693

A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.

Completed Phase 2 Last updated 18 May 2011
What this trial tests

Phase 2 trial testing Norprolac in Ovarian Hyperstimulation Syndrome in 182 participants. Completed in 1 May 2008.

Timeline
1 June 2006
Primary endpoint
1 August 2007
1 May 2008

Quick facts

Lead sponsorFerring Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment182
Start date1 June 2006
Primary completion1 August 2007
Estimated completion1 May 2008
Sites7 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 21 to 37, female only, with Ovarian Hyperstimulation Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial.
    Busso C, Fernández-Sánchez M, García-Velasco JA, Landeras J, et al · · 2010 · cited 36× · PMID 20139430 · DOI 10.1093/humrep/deq005

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Trials by the same sponsor.

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