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

Anovulation Clinical Trial

Official title:

Protocol for Drug Use Investigation of Follistim Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00920634
• Other study ID #: P06132
• Status: Completed
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anovulation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of ovulation		3 months, from initiation of treatment to confirmation of pregnancy.
Secondary	Pregnancy outcome		3 months, from initiation of treatment to confirmation of pregnancy.