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

Protocol for Drug Use Investigation of Follistim Injection

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.

Study Overview

• Status: Completed
• Conditions: Anovulation
• Intervention / Treatment: Drug: Follitropin beta

• Study Type: Observational
• Enrollment (Actual): 384

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Japanese 300 patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of ovulation	3 months, from initiation of treatment to confirmation of pregnancy.

Secondary Outcome Measures

Outcome Measure	Time Frame
Pregnancy outcome	3 months, from initiation of treatment to confirmation of pregnancy.

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 12, 2009
• First Posted (Estimate): June 15, 2009

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Anovulation; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone
• Other Study ID Numbers: P06132