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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00920634

Collaborator

(none)

384

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anovulation	Drug: Follitropin beta

Study Design

Study Type:

Observational

Actual Enrollment :

384 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Protocol for Drug Use Investigation of Follistim Injection

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Occurrence of ovulation [3 months, from initiation of treatment to confirmation of pregnancy.]

Secondary Outcome Measures

Pregnancy outcome [3 months, from initiation of treatment to confirmation of pregnancy.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00920634

Other Study ID Numbers:

P06132

First Posted:

Jun 15, 2009

Last Update Posted:

Feb 4, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Anovulation

Follicle Stimulating Hormone

Study Results

No Results Posted as of Feb 4, 2022