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)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00598208
First received: January 10, 2008
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Fertilization
Drug: corifollitropin alfa
Drug: Follitropin beta injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open Label, Randomized 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 Hyperstimulation Protocol for IVF or ICSI.

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of cumulus-oocyte-complexes retrieved [ Time Frame: 1 cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment failure rate [ Time Frame: 1 cycle ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: May 2003
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
60 µg Org 36286 (corifollitropin alfa)
Drug: 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.
Other Name: Org 36286
Experimental: 2
120 µg Org 36286 (corifollitropin alfa)
Drug: 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.
Other Name: Org 36286
Experimental: 3
180 µg Org 36286 (corifollitropin alfa)
Drug: 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.
Other Name: Org 36286
Active Comparator: 4
Follitropin beta injection
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.
Other Names:
  • Follistim®
  • Puregon®

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00598208     History of Changes
Other Study ID Numbers: 38826
Study First Received: January 10, 2008
Last Updated: October 2, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Schering-Plough:
In-vitro fertilization

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

ClinicalTrials.gov processed this record on April 17, 2014