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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00598208
First received: January 10, 2008
Last updated: May 30, 2014
Last verified: May 2014
  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 Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00598208     History of Changes
Other Study ID Numbers: P06055, 38826
Study First Received: January 10, 2008
Last Updated: May 30, 2014
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 Merck Sharp & Dohme Corp.:
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 September 30, 2014