Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00988260
First received: October 1, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Controlled Ovarian Stimulation
Drug: Ganirelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Bridging Trial of Org 37462

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of Luteinizing Hormone (LH) rise [ Time Frame: During treatment (1-14 days) ] [ Designated as safety issue: No ]
  • Intrauterine vital pregnancy rate [ Time Frame: 5-6 weeks after embryo transfer (ET) ] [ Designated as safety issue: No ]

Enrollment: 266
Study Start Date: March 2003
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00988260     History of Changes
Other Study ID Numbers: P05969
Study First Received: October 1, 2009
Last Updated: May 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 01, 2014