Status:

COMPLETED

Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)

Lead Sponsor:

Organon and Co

Conditions:

Anovulation

Eligibility:

FEMALE

Brief Summary

The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovu...

Eligibility Criteria

Inclusion

  • Patients who underwent IVF

Exclusion

  • Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
  • Pregnant or possible pregnant women, or lactating women
  • Patients with undiagnosed atypical vaginal bleeding
  • Patients with a history of hypersensitivity to any of the ingredients of this product
  • Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease

Key Trial Info

Start Date :

July 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

384 Patients enrolled

Trial Details

Trial ID

NCT00920634

Start Date

July 1 2007

End Date

March 1 2009

Last Update

February 4 2022

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