Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00920361
First received: June 12, 2009
Last updated: March 5, 2014
Last verified: March 2014

June 12, 2009
March 5, 2014
November 2005
March 2009   (final data collection date for primary outcome measure)
Number of retrieved oocytes [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00920361 on ClinicalTrials.gov Archive Site
Pregnancy outcome [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
Designated Drug Use Investigation 1 of Follistim Injection

To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method.

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Japanese 1100 patients

Fertilization in Vitro
Drug: Follitropin beta
Normally, Follistim Injection 150 or 225 IU will be administered (s.c. or i.m.) once a day for 4 days as follitropin beta (genetical recombination). The dosage will be adapted to growth of follicles (75-375 IU for 6-12 days, in general). If more than 3 follicles of mean diameter 16-20 mm are confirmed by ultrasound tomography, ovulation will be stimulated by using Human Chorionic Gonadotropin (hCG) drugs.
1
Patients who underwent IVF
Intervention: Drug: Follitropin beta
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1664
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00920361
P06130
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP