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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Follicle Stimulating Hormone

Criteria

Inclusion Criteria:

• Patients who underwent IVF

Exclusion Criteria:

• 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