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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00920634
First received: June 12, 2009
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 Intervention
Anovulation
Drug: Follitropin beta

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

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

Primary Outcome Measures:
  • Occurrence of ovulation [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy outcome [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Japanese 300 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: NCT00920634     History of Changes
Other Study ID Numbers: P06132
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:
Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014