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

Organon

Status: Completed

Conditions: Anovulation

Treatments: Drug: Follitropin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT00920634

P06132

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

384 participants in 1 patient group

1

Description:

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

Treatment:

Drug: Follitropin beta