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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416987
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief 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®.


Condition or disease Intervention/treatment
Infertility Drug: Pergoveris®

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
Actual Study Start Date : August 14, 2011
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : May 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility


Intervention Details:
  • Drug: Pergoveris®
    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 Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile participants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416987


Locations
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Korea, Republic of
Research site
Seoul, Korea, Republic of, 04619
Research site
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Ltd.
Investigators
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Study Director: Medical Responsible Merck Ltd.
  Study Documents (Full-Text)

Documents provided by Merck KGaA, Darmstadt, Germany:
Study Protocol  [PDF] July 23, 2015
Statistical Analysis Plan  [PDF] February 15, 2017

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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01416987    
Other Study ID Numbers: EMR200061-507
First Posted: August 15, 2011    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female