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Sponsored by: |
IBSA Institut Biochimique SA |
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Information provided by: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT00828191 |
Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.
Condition | Intervention | Phase |
---|---|---|
In Vitro Fertilization |
Drug: Progesterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF) |
Estimated Enrollment: | 800 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Progesterone SC: Experimental |
Drug: Progesterone
25 mg, once a day, SC
|
Progesterone Tablets: Active Comparator |
Drug: Progesterone
100 mg, twice a day, vaginally
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Ages Eligible for Study: | 18 Years to 42 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clarence Jones, Dr. | +1 (714) 8488084 |
United States, California | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Valerie L. Baker, M.D. | |
Reproductive Partners Medical Group, Inc. | Recruiting |
Redondo Beach, California, United States, 90277 | |
Contact: Bill Yee, M.D. | |
Fertility Physicians of Northern California | Recruiting |
San Jose, California, United States, 95124 | |
Contact: Karen Purcell, M.D. | |
Fertility and Surgical Associates of California | Recruiting |
Thousand Oaks, California, United States, 91360 | |
Contact: Gary Hubert, M.D. | |
United States, Florida | |
Center for Reproductive Medicine | Recruiting |
Orlando, Florida, United States, 32804 | |
Contact: Gary DeVane, M.D. | |
United States, Idaho | |
Idaho Center for Reproductive Medicine | Recruiting |
Boise, Idaho, United States, 83702 | |
Contact: Russell Foulk, M.D. | |
United States, Texas | |
Center for Assisted Reproduction | Recruiting |
Bedford, Texas, United States, 76022 | |
Contact: Kevin Doody, M.D. | |
United States, Washington | |
Seattle Reproductive Medicine | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Michael R. Soules, M.D. |
Responsible Party: | IBSA Institut Biochimique SA ( Clarence Jones ) |
Study ID Numbers: | 07USA/Prg05 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00828191 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Luteal support in IVF |
Progesterone Hormone Antagonists Progestins Hormones, Hormone Substitutes, and Hormone Antagonists Hormones |
Progesterone Progestins Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |