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

NCT ID: NCT00920634

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 384 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-03-31

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction

Follitropin beta

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P06132

Identifier Type: -

Identifier Source: org_study_id