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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00805935 |
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 PCOS but otherwise healthy females undergoing IVF.
Each study center will follow its 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 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 times during the cycle (Stimulation Day 6, Day of hCG, and first serum pregnancy test) for estradiol (E2), progesterone (P4) and hCG labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
Condition | Intervention | Phase |
---|---|---|
Polycystic Ovarian Syndrome 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 |
Official Title: | A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MENOPUR-ENDOMETRIN
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Drug: MENOPUR-ENDOMETRIN |
2: Experimental
MENOPUR-PROGESTERONE IN OIL
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Drug: MENOPUR-PROGESTERONE IN OIL |
3: Active Comparator
FOLLISTIM-ENDOMETRIN
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Drug: FOLLISTIM-ENDOMETRIN |
4: Active Comparator
FOLLISTIM-PROGESTERONE IN OIL
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Drug: FOLLISTIM-PROGESTERONE IN OIL |
Ages Eligible for Study: | 18 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnosed with PCOS, using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome])
Exclusion Criteria:
Contact: Clinical Development Support | DK0-Disclosure@ferring.com |
United States, Colorado | |
Conceptions Reproductive Associates of Colorado | Recruiting |
Littleton, Colorado, United States, 80129 | |
United States, Illinois | |
Fertility Centers of Illinois | Recruiting |
Chicago, Illinois, United States, 60610 | |
United States, New York | |
Weill Cornell Medical College | Recruiting |
New York, New York, United States, 10021 | |
Center for Women's Reproductive Care-Columbia University | Recruiting |
New York, New York, United States, 10019 | |
United States, Rhode Island | |
Women & Infants' Hospital of RI | Recruiting |
Providence, Rhode Island, United States, 02905 |
Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
Responsible Party: | Ferring Pharmaceuticals ( Hjort, Director ) |
Study ID Numbers: | 2008-05 |
Study First Received: | December 9, 2008 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00805935 History of Changes |
Health Authority: | United States: Institutional Review Board |
Healthy, pre-menopausal women, age 18-42, with a history of PCOS and infertility and requiring IVF |
Infertility Progesterone Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Ovarian Diseases Healthy Genital Diseases, Male Cysts |
Hormones Polycystic Ovarian Syndrome Genital Diseases, Female Progestins Menotropins Polycystic Ovary Syndrome Endocrinopathy Ovarian Cysts Menopause |
Infertility Progesterone Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Ovarian Diseases Reproductive Control Agents Hormones Genital Diseases, Female Pathologic Processes Syndrome Therapeutic Uses Progestins |
Menotropins Disease Endocrine System Diseases Cysts Genital Diseases, Male Pharmacologic Actions Adnexal Diseases Neoplasms Fertility Agents, Female Polycystic Ovary Syndrome Fertility Agents Ovarian Cysts |