Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
- Registration Number
- NCT00920634
- Lead Sponsor
- Organon and Co
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 384
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Follitropin beta Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction
- Primary Outcome Measures
Name Time Method Occurrence of ovulation 3 months, from initiation of treatment to confirmation of pregnancy.
- Secondary Outcome Measures
Name Time Method Pregnancy outcome 3 months, from initiation of treatment to confirmation of pregnancy.