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

February 1, 2022 updated by: Organon and Co

A Phase II Bridging Trial of Org 37462

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
EXPERIMENTAL: Ganirelix 0.25 mg
Drug: Ganirelix
Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
EXPERIMENTAL: Ganirelix 0.5 mg
Drug: Ganirelix
Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest
Drug: Ganirelix
Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
Other Names:
  • Ganirelix Acetate
  • Org 37462
  • Orgalutran
  • SCH 900761
  • Ganirest

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2003

Primary Completion (ACTUAL)

April 12, 2004

Study Completion (ACTUAL)

April 12, 2004

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05969

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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