Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)
1 other identifier
observational
384
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedFebruary 4, 2022
February 1, 2022
1.7 years
June 12, 2009
February 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of ovulation
3 months, from initiation of treatment to confirmation of pregnancy.
Secondary Outcomes (1)
Pregnancy outcome
3 months, from initiation of treatment to confirmation of pregnancy.
Study Arms (1)
1
Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction
Interventions
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.
Eligibility Criteria
Japanese 300 patients
You may qualify if:
- Patients who underwent IVF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
July 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 4, 2022
Record last verified: 2022-02