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

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®.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research site, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants, who were eligible for Pergoveris® treatment according to the indication in the national label of Pergoveris®. The national label approved by Korea Food & Drug Administration is "Pergoveris® in association with a follicle stimulating hormone(FSH) preparation was recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these participants were defined by an endogenous serum LH level less than (<)1.2 International units per liter IU/L"

Exclusion criteria

According to national label

Treatment and study plan

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.

Primary outcomes

Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)

Time frame: 2463 days

Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.

Secondary outcomes

Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography

Time frame: 2463 days

Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.
Number of Participants With Clinical Pregnancy as Per Safety Analysis Set

Time frame: 2463 days

The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.
Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set

Time frame: 2463 days

The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

Merck Ltd.

Registry information

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Aug 15, 2011
Registry last updated: Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed