NCT00920361

Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

Designated Drug Use Investigation 1 of Follistim Injection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,664 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method. 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

• Fertilization in Vitro

Interventions

Type	Name	Description
DRUG	Follitropin beta	Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-06-15
• Last updated: 2022-02-04