| May 27, 2008 |
| April 22, 2009 |
| April 2008 |
| August 2008 (final data collection date for primary outcome measure) |
| Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00685906 on ClinicalTrials.gov Archive Site |
- Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. ] [ Designated as safety issue: No ]
- Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. ] [ Designated as safety issue: No ]
- Safety and tolerability of AZD6140 when co-administered with Nordette® [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: No ]
|
- Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. ] [ Designated as safety issue: No ]
- Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. ] [ Designated as safety issue: No ]
- Safety and tolerability of AZD6140 when co-administered with Nordette® [ Time Frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. ] [ Designated as safety issue: No ]
|
| |
| AZD6140 Oral Contraceptive Interaction Study |
| 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 |
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. |
| |
| Phase I |
| Interventional |
| Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Healthy |
- Drug: AZD6140
- Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)
|
| |
| |
| |
| Completed |
| 24 |
| August 2008 |
| August 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Females who are healthy, non-pregnant, not planning pregnancy within the study period, non-breast-feeding, and pre-menopausal
- Either currently taking Nordette® which was well tolerated for at least two months prior to randomisation with no history of break-through bleeding, or, willing to take Nordette for 2 months prior to receiving the study drug
- Females of child-bearing potential must be willing to use at least 1 additional medically approved non-hormonal barrier contraceptive method (for example, condom or diaphragm) that contains spermicide
Exclusion Criteria:
- History of intolerance (e.g. adverse events) to any oral contraceptive or AZD6140
- History of blood vessel or bleeding conditions that would make the volunteer more prone to bleeding
- History or presence of significant medical problems
- Women who are current smokers
|
| Female |
| 18 Years to 45 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00685906 |
| Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals |
| D5130C00042, AZD6140/OC Study |
| AstraZeneca |
|
| Study Director: |
Kathleen Butler, MD |
AstraZeneca |
|
| Principal Investigator: |
Audrey , Martinez, MD |
SeaView Research |
|
|
| AstraZeneca |
| April 2009 |
