Japanese Bridging Trial of Org 37462 (Study P05969)(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: NCT00988260
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to find the optimal dose of Org 37462 for Japanese females undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm injection (IVF-ICSI).

Condition or disease Intervention/treatment Phase
Controlled Ovarian Stimulation Drug: Ganirelix Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Bridging Trial of Org 37462
Actual Study Start Date : February 3, 2003
Actual Primary Completion Date : April 12, 2004
Actual Study Completion Date : April 12, 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ganirelix 0.125 mg Drug: Ganirelix
Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Org 37462
  • SCH 900761
  • Orgalutran
  • Ganirelix Acetate
  • Ganirest

Experimental: Ganirelix 0.25 mg Drug: Ganirelix
Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Org 37462
  • SCH 900761
  • Orgalutran
  • Ganirelix Acetate
  • Ganirest

Experimental: Ganirelix 0.5 mg Drug: Ganirelix
Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Org 37462
  • SCH 900761
  • Orgalutran
  • Ganirelix Acetate
  • Ganirest

Primary Outcome Measures :
  1. Incidence of Luteinizing Hormone (LH) rise [ Time Frame: During treatment (1-14 days) ]
  2. Intrauterine vital pregnancy rate [ Time Frame: 5-6 weeks after embryo transfer (ET) ]

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Japanese females of infertile married couples with an indication for COH and IVF with or without ICSI.
  • At least 20 but not older than 39 years of age at the time of screening.
  • A body mass index (BMI) between 18 and 29.
  • Normal menstrual cycle with a range of 24-35 days and an intra-individual variation of plus or minus 3 days (but never outside the 24-35 days range).
  • Infertile couple that is willing to give written informed consent.
  • Determination of inclusion criteria

    • is determined in view of the planned therapeutic indication.
    • is determined based on ethical considerations for the subjects (not younger than 20) and also in view of the planned therapeutic indication (not older than 39)
    • is determined to avoid bias on the effects of Org 37462 by emaciation and obesity.
    • is determined to avoid the influences of endogenous hormones considering the purpose of this trial to select the minimal effective dose of Org 37462.
    • is determined from the ethical consideration of the subjects.

Exclusion Criteria:

  • History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS) or polycystic ovaries according to USS, (treated) hyperprolactinemia or evidence of ovarian dysfunction.
  • History of non- or low- ovarian response to FSH/hMG treatment.
  • Abnormal cervical smear according to the Papanicolaou (>= class III) or Bethesda (>= CIN 1) scale.
  • History of/or current Type I hypersensitivity (urticaria, eczema, hay fever, asthma), meaning that the subject is using prescribed medication on a regular basis or that the subjects history is prohibitive for Org 37462 treatment according to the clinical opinion of the sub-investigator.
  • Any hormone value outside the reference range during the early follicular phase as measured by the central laboratory (Japan) [FSH, LH, E2, P, androstenedione (AD), dehydroepiandrosterone sulphate (DHEAS), testosterone (T), thyroid stimulating hormone (TSH) and prolactin].
  • Any clinically significant abnormal laboratory value of the central laboratory (Japan) (routine hematology, blood biochemistry).
  • Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of both ovaries, thus excluding subjects with only one ovary.
  • Contra-indications for the use of gonadotropins i.e.,

    • tumors of ovary, breast, uterus, pituitary or hypothalamus.
    • pregnancy or lactation.
    • undiagnosed vaginal bleeding.
    • hypersensitivity to any of the substances in recFSH (FSH, sucrose, sodium citrate, polysorbate 20 and sodium chloride, L-methionine).
    • ovarian cysts or enlarged ovaries not related to PCOS.
    • malformation of the sexual organs incompatible with pregnancy.
    • fibroid tumors of the uterus incompatible with pregnancy.
  • Use of hormonal preparations within 1 month prior to screening.
  • Hypertension (systolic blood pressure >150 mm Hg and/or diastolic blood pressure >90 mm Hg) or treated hypertension.
  • Epilepsia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease.
  • Administration of investigational drugs within 3 months prior to screening.

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00988260     History of Changes
Other Study ID Numbers: P05969
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017

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