Menopur Mixed Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01417195
First received: July 28, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

Subjects undergoing Assisted Reproductive Technology will self-administer Menopur and Bravelle mixed in the same syringe or Menopur alone. The study will assess the subject's ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.


Condition Intervention Phase
Infertility
Drug: Urofollitropin
Drug: Menotropin
Phase 4

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 Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Combination of Menopur® and Bravelle® With Menopur® Alone in Subjects Undergoing Assisted Reproductive Technology (ART)

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: Expected average of about 36 hours post hCG (human chorionic gonadotrophin) administration ] [ Designated as safety issue: No ]
  • Number of fertilized oocytes [ Time Frame: Expected average of about 20 hours after IVF (in-vitro fertilisation) insemination or ICSI (intracytoplasmic sperm injection) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of ovarian hyperstimulation syndrome [ Time Frame: Expected average of about 6 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of Adverse Events [ Time Frame: Expected average of about 6 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory results and cycle cancellations [ Time Frame: Expected average of about 6 weeks ] [ Designated as safety issue: Yes ]
  • Subject's comprehension of how to mix and store the combination of Menopur and Bravelle measured by the Assessor Questionnaire [ Time Frame: Expected average of about 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menopur and Bravelle combination
The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
Drug: Urofollitropin
Other Names:
  • Bravelle®
  • purified form of follicle-stimulating hormone (FSH)
Drug: Menotropin
Other Names:
  • Menopur®
  • HP-hMG
  • highly purified menotrophin
Active Comparator: Menopur alone
The initial daily dose consisted of 225 IU of Menopur, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
Drug: Menotropin
Other Names:
  • Menopur®
  • HP-hMG
  • highly purified menotrophin

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-menopausal female subjects
  • Diagnosis of tubal or unexplained infertility (including endometriosis stage I/II)
  • Male partner with adequate semen analysis
  • Eligible for IVF (in-vitro fertilisation)or ICSI (intracytoplasmic sperm injection) treatment

Exclusion Criteria:

  • BMI of ≤18 and ≥32 kg/m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417195

Locations
United States, Colorado
Colorado Center for Reproductive Medicine
Long Tree, Colorado, United States
United States, Florida
Women's Medical Research Group
Clearwater, Florida, United States
United States, Georgia
Reproductive Biology Associates
Atlanta, Georgia, United States
United States, Illinois
Fertility Center of Illinois
Chicago, Illinois, United States
The Advanced IVF Institute
Naperville, Illinois, United States
United States, Maryland
Shady Grove Fertility
Rockville, Maryland, United States
United States, Texas
The Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility
Houston, Texas, United States
Center for Reproductive Medicine
Webster, Texas, United States
United States, Washington
Seattle Reproductive Medicine
Seattle, Washington, United States
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01417195     History of Changes
Other Study ID Numbers: FE999906 CS12
Study First Received: July 28, 2011
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Assisted Reproductive Technology

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Follicle Stimulating Hormone
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 14, 2014