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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00802360 |
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 |
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 |
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 |
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.
Ages Eligible for Study: | 18 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clinical Development Support | DK0-Disclosure@ferring.com |
United States, Texas | |
Center for Assisted Reproduction | Recruiting |
Bedford, Texas, United States, 76022 |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
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 |
Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF |
Genital Diseases, Female Infertility Progesterone Hormone Antagonists Progestins Menotropins |
Hormones, Hormone Substitutes, and Hormone Antagonists Healthy Genital Diseases, Male Hormones Menopause |
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 |