Controlled Ovarian StimulationPhase 2NCT00988260
Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)
A Phase 2 study testing Ganirelix in people with Controlled Ovarian Stimulation, run by Organon and Co.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Controlled Ovarian Stimulation
- What is being tested?
- Ganirelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2003to 12 Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: 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).
- Conditions
- Controlled Ovarian Stimulation
- Being tested
- Ganirelix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanirelixDrug
Also called Org 37462, SCH 900761, Orgalutran, Ganirelix Acetate
Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days
GanirelixDrug
Also called Org 37462, SCH 900761, Orgalutran, Ganirelix Acetate
Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days
GanirelixDrug
Also called Org 37462, SCH 900761, Orgalutran, Ganirelix Acetate
Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ganirelix 0.125 mg | Experimental | Not described Receives: Drug: Ganirelix |
| Ganirelix 0.25 mg | Experimental | Not described Receives: Drug: Ganirelix |
| Ganirelix 0.5 mg | Experimental | Not described Receives: Drug: Ganirelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Luteinizing Hormone (LH) rise
Measured: During treatment (1-14 days)
Intrauterine vital pregnancy rate
Measured: 5-6 weeks after embryo transfer (ET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study start3 Feb 2003
- Primary completion12 Apr 2004
- Study completion12 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled Ovarian StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988260
- Sponsor's protocol ID
- P05969
- Status last verified
- Feb 2022
- First submitted
- 1 Oct 2009
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Bridging Trial of Org 37462
- ClinicalTrials.gov ID
- NCT00988260
- Acronym / sponsor ID
- P05969
- Conditions
- Controlled Ovarian Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2003 (actual)
- Primary completion
- 12 Apr 2004 (actual)
- Study completion
- 12 Apr 2004 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ganirelix 0.125 mg | Experimental | Drug: Ganirelix |
| Ganirelix 0.25 mg | Experimental | Drug: Ganirelix |
| Ganirelix 0.5 mg | Experimental | Drug: Ganirelix |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (19 listed)
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanirelixAlso: Org 37462, SCH 900761, Orgalutran, Ganirelix AcetateGanirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days | Drug | Ganirelix 0.125 mg |
| GanirelixAlso: Org 37462, SCH 900761, Orgalutran, Ganirelix AcetateGanirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days | Drug | Ganirelix 0.25 mg |
| GanirelixAlso: Org 37462, SCH 900761, Orgalutran, Ganirelix AcetateGanirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days | Drug | Ganirelix 0.5 mg |
Primary outcome
Incidence of Luteinizing Hormone (LH) rise
Time frame: During treatment (1-14 days)
Intrauterine vital pregnancy rate
Time frame: 5-6 weeks after embryo transfer (ET)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ganirelix in people with Controlled Ovarian Stimulation, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Luteinizing Hormone (LH) rise (time frame: During treatment (1-14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.