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

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ClinicalTrials.gov Identifier: NCT00920361
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

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.


Condition or disease Intervention/treatment
Fertilization in Vitro Drug: Follitropin beta

Study Type : Observational
Actual Enrollment : 1664 participants
Time Perspective: Prospective
Official Title: Designated Drug Use Investigation 1 of Follistim Injection
Study Start Date : November 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Group/Cohort Intervention/treatment
1
Patients who underwent IVF
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.



Primary Outcome Measures :
  1. Number of retrieved oocytes [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ]

Secondary Outcome Measures :
  1. Pregnancy outcome [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese 1100 patients
Criteria

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00920361     History of Changes
Other Study ID Numbers: P06130
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs