Status:

COMPLETED

Post Marketing Surveillance of MENOPUR

Lead Sponsor:

Ferring Pharmaceuticals

Conditions:

Infertility

Eligibility:

FEMALE

18+ years

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.

Eligibility Criteria

Inclusion

  • Anovulation in women (WHO group II)
  • Controlled ovarian hyperstimulation cases for ART

Exclusion

  • Hypersensitivity to MENOPUR
  • Pregnancy, lactation or contraindication to pregnancy
  • Ovarian cysts not related to polycystic ovarian syndrome
  • Abnormal uterine bleeding
  • Tumors in uterus, ovaries and breasts
  • Ovarian hyperstimulation syndrome
  • Thromboembolism or history of it
  • Infertile due to other reason than anovulation
  • High FSH level indication primary ovarian failure

Key Trial Info

Start Date :

December 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 1 2014

Estimated Enrollment :

2501 Patients enrolled

Trial Details

Trial ID

NCT01202123

Start Date

December 1 2008

End Date

February 1 2014

Last Update

February 21 2014

Active Locations (19)

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Page 1 of 5 (19 locations)

1

Busan Maria hospital

Busan, Busan, South Korea

2

Daegu Maria

Daegu, Daegu, South Korea

3

Daejeon Maria

Daejeon, Daejeon, South Korea

4

Daejeon Seoul Women Hospital

Daejeon, Daejeon, South Korea