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

This study has been completed.
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01416987
First received: August 12, 2011
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

This prospective study will collect safety information from more than 600 patients treated with Pergoveris®.

During the Post-Marketing Surveillance (PMS) period, data about the patient´s background, patient'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) will be collected for study purposes.

The post marketing surveillance is based on all cases treated with Pergoveris®.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Frequency and severity of all adverse events regardless of the causal relationship to Pergoveris® [ Time Frame: 30 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical pregnancy [ Time Frame: 30 month ] [ Designated as safety issue: No ]
  • Percentage of patients with more than one follicle greater than 17mm on day of human chorionic gonadotrophin (HCG) administration [ Time Frame: 30 month ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: August 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infertile patients

Criteria

Inclusion Criteria:

  • Patients, who are 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 is recommended for the stimulation of follicular development in women with severe Luteinizing Hormone (LH) and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L"

Exclusion Criteria:

  • According to national label
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416987

Locations
Korea, Republic of
Merck Serono Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck KGaA
Merck Ltd.
Investigators
Study Director: Medical Responsible Merck Ltd.
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01416987     History of Changes
Other Study ID Numbers: EMR200061-507
Study First Received: August 12, 2011
Last Updated: July 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014