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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Protocol for Drug Use Investigation of Follistim Injection

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 oligoovulation due to hypothalamus-pituitary dysfunction.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Occurrence of ovulation [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Pregnancy outcome [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ]

Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: June 12, 2009
Date Started: July 2007
Date Completion:
Last Updated: February 4, 2015
Last Verified: February 2015