Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Protocol for Drug Use Investigation of Follistim Injection|
- Occurrence of ovulation [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
- Pregnancy outcome [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction
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.