A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)

NCT ID: NCT00598208

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-19
• Study Completion Date: 2004-03-15

Brief Summary

The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.

Conditions

Fertilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

60 µg Org 36286 (corifollitropin alfa)

Group Type: EXPERIMENTAL

corifollitropin alfa

Intervention Type: DRUG

On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.

2

120 µg Org 36286 (corifollitropin alfa)

Group Type: EXPERIMENTAL

corifollitropin alfa

Intervention Type: DRUG

On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.

3

180 µg Org 36286 (corifollitropin alfa)

Group Type: EXPERIMENTAL

corifollitropin alfa

Intervention Type: DRUG

On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.

4

Follitropin beta injection

Group Type: ACTIVE_COMPARATOR

Follitropin beta injection

Intervention Type: DRUG

Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.

Interventions

corifollitropin alfa

On Cycle Day 2, a single injection of 60 μg, 120 μg, or 180 μg Org 36286 was administered. One week later (Treatment Day 8), treatment was continued with a fixed daily subcutaneous (SC) dose of 150 IU Puregon® up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and up to and including the Day of hCG. The maximum total treatment duration was 19 days.

Intervention Type: DRUG

Follitropin beta injection

Starting on Cycle Day 2, a fixed daily dose of 150 IU Puregon® SC was administered for the entire stimulation period up to and including the Day of hCG. Orgalutran® (0.25 mg) was administered once daily SC starting on Treatment Day 5 and given up to and including the day of hCG. The maximum total treatment duration was 19 days.

Intervention Type: DRUG

Other Intervention Names

Org 36286; Follistim®; Puregon®

Eligibility Criteria

Inclusion Criteria

• Females of couples with an indication for COH and IVF or ICSI;
• >=18 and <=39 years of age at the time of signing informed consent;
• BMI >=18 and <=29 kg/m^2;
• Normal menstrual cycle length: 24-35 days;
• Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
• Willing and able to sign informed consent.

Exclusion Criteria

• History of/or any current (treated) endocrine abnormality;
• History of ovarian hyperstimulation syndrome (OHSS);
• History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
• More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
• History of non- or low ovarian response to FSH/hMG treatment;
• Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
• Any clinically relevant abnormal laboratory value;
• Less than 2 ovaries;
• Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
• Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
• Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
• History of presence of alcohol or drug abuse within 12 months prior to signing informed consent;
• Previous use of Org 36286;
• Use of hormonal preparations within 1 month prior to randomization;
• Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
• Administration of investigational drugs within three months prior to signing informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.

Reference Type: DERIVED

PMID: 26991902 (View on PubMed)

Corifollitropin Alfa Dose-finding Study Group. A randomized dose-response trial of a single injection of corifollitropin alfa to sustain multifollicular growth during controlled ovarian stimulation. Hum Reprod. 2008 Nov;23(11):2484-92. doi: 10.1093/humrep/den288. Epub 2008 Aug 6.

Reference Type: DERIVED

PMID: 18684735 (View on PubMed)

Other Identifiers

38826

Identifier Type: -

Identifier Source: secondary_id

P06055

Identifier Type: -

Identifier Source: org_study_id