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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
  Purpose

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 Intervention
Fertilization in Vitro
Drug: Follitropin beta

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Designated Drug Use Investigation 1 of Follistim Injection

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of retrieved oocytes [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy outcome [ Time Frame: 2 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]

Enrollment: 1664
Study Start Date: November 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00920361     History of Changes
Other Study ID Numbers: P06130
Study First Received: June 12, 2009
Last Updated: March 5, 2014
Health Authority: Japan:Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on November 25, 2014