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MENOPUR® Versus FOLLISTIM®
This study is currently recruiting participants.
Verified by Ferring Pharmaceuticals, February 2009
First Received: December 3, 2008   Last Updated: February 9, 2009   History of Changes
Sponsored by: Ferring Pharmaceuticals
Information provided by: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00802360
  Purpose

To compare the efficacy and safety of MENOPUR® with that of FOLLISTIM® in patients who are undergoing GnRH antagonist IVF cycles


Condition Intervention Phase
Infertility
Drug: Menopur-Endometrin
Drug: Menopur-Progesterone in Oil
Drug: Follistim-Endometrin
Drug: Follistim-Progesterone in Oil
Phase IV

MedlinePlus related topics: Infertility
Drug Information available for: Progesterone Menotropins Urofollitropin Follitropin beta
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles

Further study details as provided by Ferring Pharmaceuticals:

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
1
Menopur-Endometrin
Drug: Menopur-Endometrin
2
Menopur-Progesterone in Oil
Drug: Menopur-Progesterone in Oil
3: Active Comparator
Follistim-Endometrin
Drug: Follistim-Endometrin
4: Active Comparator
Follistim-Progesterone in Oil
Drug: Follistim-Progesterone in Oil

Detailed Description:

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing IVF. Each study center will follow its study center standard practice for IVF within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to Menopur® or Follistim Pen® for stimulation and Endometrin® or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per IVF protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and hCG (Stimulation Day 6, Day of hCG, and first serum pregnancy test). All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

  Eligibility

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

Inclusion Criteria:

  1. Pre-menopausal females between the ages of 18 and 42 years
  2. Body mass index (BMI) of 18-34
  3. Early follicular phase (day 2-4) FSH <15 IU/L and E2 within normal limits
  4. Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
  5. Transvaginal ultrasound at screening consistent with findings aquedate for assisted reproductive technology (ART) with respect to uterus and adnexa
  6. Signed informed consent

Exclusion Criteria:

  1. Gestational or surrogate carrier, donor oocyte
  2. Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
  3. Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
  4. Previous IVF or ART failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed IVF cycles.
  5. History of recurrent pregnancy loss (>2).
  6. Presence of abnormal uterine bleeding of undetermined origin
  7. Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
  8. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
  9. Participation in any experimental drug study within 30 days prior to Screening
  10. Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802360

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
United States, Texas
Center for Assisted Reproduction Recruiting
Bedford, Texas, United States, 76022
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers: 2008-04
Study First Received: December 3, 2008
Last Updated: February 9, 2009
ClinicalTrials.gov Identifier: NCT00802360     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Progesterone
Hormone Antagonists
Progestins
Menotropins
Hormones, Hormone Substitutes, and Hormone Antagonists
Healthy
Genital Diseases, Male
Hormones
Menopause

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

ClinicalTrials.gov processed this record on May 07, 2009