Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00319163 |
Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.
Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: levonorgestrel/ethinyl estradiol |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women |
Estimated Enrollment: | 26 |
Study Start Date: | May 2006 |
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0858A2-108 |
Study First Received: | April 26, 2006 |
Last Updated: | February 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00319163 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oral contraceptive therapeutic equivalency contraceptives, oral, combined |
Estrogens Contraceptive Agents Benzoates Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol |
Healthy Estradiol 17 beta-cypionate Hormones Estradiol Contraceptives, Oral, Combined Estradiol 3-benzoate Levonorgestrel Polyestradiol phosphate |
Estrogens Contraceptive Agents Estradiol valerate Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Estradiol 17 beta-cypionate Reproductive Control Agents |
Hormones Pharmacologic Actions Estradiol Contraceptives, Oral, Combined Therapeutic Uses Estradiol 3-benzoate Levonorgestrel Contraceptives, Oral, Synthetic Polyestradiol phosphate |