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Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00685906 |
The purpose of this study is to examine the effect of co-administration of AZD6140 and Nordette® on the blood levels of certain female hormones.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: AZD6140 Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomised, Double-Blind, Two-Way Crossover Study to Determine the Effects of Co-Administration of AZD6140 and Nordette® (Combination of Levonorgestrel and Ethinyl Estradiol) After Multiple Oral Doses in Healthy Female Volunteers |
Estimated Enrollment: | 24 |
Study Start Date: | April 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AZD6140
90 mg tablet taken by mouth 2 times a day for 21 days per cycle
|
2: Active Comparator |
Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)
1 tablet taken by mouth once a day for 28 days per cycle
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Research Site | |
Miami, Florida, United States |
Study Director: | Kathleen Butler, MD | AstraZeneca |
Principal Investigator: | Audrey , Martinez, MD | SeaView Research |
Responsible Party: | AstraZeneca Pharmaceuticals ( Jay Horrow, MD, Medical Science Director, AZD6140 ) |
Study ID Numbers: | D5130C00042, AZD6140/OC Study |
Study First Received: | May 27, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00685906 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oral contraceptive birth control Healthy volunteers |
Estrogens Contraceptive Agents Hormone Antagonists Estradiol valerate Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Healthy Estradiol 17 beta-cypionate |
Contraceptives, Postcoital Hormones Estradiol Contraceptives, Oral, Combined Norgestrel Estradiol 3-benzoate Levonorgestrel Ethinyl Estradiol-Norgestrel Combination Polyestradiol phosphate |
Contraceptives, Postcoital, Synthetic Estrogens Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Ethinyl Estradiol Reproductive Control Agents |
Contraceptives, Postcoital Hormones Estradiol Pharmacologic Actions Contraceptives, Oral, Combined Levonorgestrel Therapeutic Uses Contraceptives, Oral, Synthetic Ethinyl Estradiol-Norgestrel Combination |