CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 600 enrolled
Drug / intervention
Pergoveris®drug
Likely dose
Pergoveris® 75 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/NCT01416987
NCT01416987N/ACompleted
CompareCT.gov

A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)

Merck KGaA, Darmstadt, Germany·observational·Posted Aug 15, 2011·Updated Jul 19, 2019

In Brief

An observational study evaluating Pergoveris® for Infertility. Completed, enrolled 600 participants across 2 sites.

Detailed Summary

This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical history, Pergoveris® indication, prior infertility medication, Pergoveris® treatment status, concomitant drugs, all adverse events (regardless of the causal relationship to Pergoveris®) and efficacy (follicular growth and clinical pregnancy) were collected for study purposes.The post marketing surveillance was based on all cases treated with Pergoveris®.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesSouth Korea
CollaboratorsMerck Ltd.

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 15, 2011
Enrollment StartAug 14, 2011
Primary CompletionMay 10, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.9 years ago

Interventions

Pergoveris®drug

Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.