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.

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Key information

Conditions

Anovulation Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follitropin beta

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.

Primary outcomes

Occurrence of ovulation

Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.

Secondary outcomes

Pregnancy outcome

Time frame: 3 months, from initiation of treatment to confirmation of pregnancy.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Protocol for Drug Use Investigation of Follistim Injection

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 15, 2009
Registry last updated: Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed