AZD6140 Oral Contraceptive Interaction Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD6140
* Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD6140<br>* 90 mg tablet taken by mouth 2 times a day for 21 days per cycle<br>|
| Active Comparator: 2<br> | Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)<br>* 1 tablet taken by mouth once a day for 28 days per cycle<br>* Other names: Nordette®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette® |  | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette® |  | At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2. | 
| Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette® |  | At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2. | 
| Safety and tolerability of AZD6140 when co-administered with Nordette® |  | Screening through completion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral contraceptive, birth control, Healthy volunteers