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

August 13, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
266

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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