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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920634
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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
Anovulation Drug: Follitropin beta

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Study Type : Observational
Actual Enrollment : 384 participants
Time Perspective: Prospective
Official Title: Protocol for Drug Use Investigation of Follistim Injection
Study Start Date : July 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Group/Cohort 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.

Primary Outcome Measures :
  1. Occurrence of ovulation [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ]

Secondary Outcome Measures :
  1. Pregnancy outcome [ Time Frame: 3 months, from initiation of treatment to confirmation of pregnancy. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Japanese 300 patients

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
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00920634    
Other Study ID Numbers: P06132
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs