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Sponsored by: |
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
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Information provided by: | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
ClinicalTrials.gov Identifier: | NCT00344383 |
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Condition | Intervention | Phase |
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Metrorrhagia |
Drug: Norgestimate/Ethinyl Estradiol tablet |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen |
Estimated Enrollment: | 50 |
Estimated Study Completion Date: | July 2004 |
This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops.
Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | McNeil Consumer & Specialty Pharmaceuticals Clinical Trial | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. |
Study ID Numbers: | CR008344 |
Study First Received: | June 23, 2006 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00344383 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oral contraceptive breakthrough bleeding spotting |
Estrogens Metrorrhagia Uterine Hemorrhage Benzoates Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Ethinyl Estradiol |
Uterine Diseases Estradiol 17 beta-cypionate Hemorrhage Hormones Estradiol Genital Diseases, Female Norgestimate Moxifloxacin Estradiol 3-benzoate Polyestradiol phosphate |
Estrogens Metrorrhagia Uterine Hemorrhage Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Uterine Diseases Ethinyl Estradiol Reproductive Control Agents |
Estradiol 17 beta-cypionate Hemorrhage Hormones Pharmacologic Actions Estradiol Genital Diseases, Female Norgestimate Pathologic Processes Therapeutic Uses Estradiol 3-benzoate Contraceptives, Oral, Synthetic Polyestradiol phosphate |