NCT00920634

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

Protocol for Drug Use Investigation of Follistim Injection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 384 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Anovulation

Interventions

Type	Name	Description
DRUG	Follitropin beta	For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-06-15
• Last updated: 2022-02-04