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Sponsored by: |
VIVUS, Inc. |
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Information provided by: | VIVUS, Inc. |
ClinicalTrials.gov Identifier: | NCT00821496 |
This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: ethinyl estradiol / norethindrone Drug: VI-0521 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open Label, Fixed Sequence, Single-Center Study to Evaluate the Effect of Multiple Dose Administration of VI-0521 on the Pharmacokinetics of a Single Dose of Oral Contraceptive in Healthy Female Subjects |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Oral Contraceptive: Experimental |
Drug: ethinyl estradiol / norethindrone
Oral contraceptive
Drug: VI-0521
15/92 phentermine hydrochloride/topiramate
|
This study is designed to determine if multiple oral doses of VI-0521 would alter the pharmacokinetics of an oral contraceptive in healthy female subjects.
Ages Eligible for Study: | 19 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shiyin Yee | 650-934-5240 | yee@vivus.com |
Contact: John Burnett | burnett@vivus.com |
United States, Arizona | |
MDS Pharma Services | |
Phoenix, Arizona, United States, 85283 |
Study Director: | Shiyin Yee | VIVUS, Inc. |
Principal Investigator: | Scott Sharples, M.D. | MDS Pharma Services |
Responsible Party: | Vivus, Inc. ( Shiyin Yee ) |
Study ID Numbers: | OB-108 |
Study First Received: | January 6, 2009 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00821496 |
Health Authority: | United States: Food and Drug Administration |
Multiple dose administration Oral Contraceptives |
Modicon Estradiol valerate Ethinyl Estradiol Healthy Estradiol 17 beta-cypionate Norinyl Phentermine |
Estradiol Norethindrone Estradiol 3-benzoate Topiramate Mestranol Polyestradiol phosphate Norethindrone acetate |
Estrogens Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents |
Hormones Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral, Sequential Contraceptives, Oral, Hormonal Therapeutic Uses Contraceptives, Oral, Synthetic |