AZD6140 Oral Contraceptive Interaction Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00685906

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD6140 Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD6140 90 mg tablet taken by mouth 2 times a day for 21 days per cycle
Active Comparator: 2	Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) 1 tablet taken by mouth once a day for 28 days per cycle Other Names: Nordette®

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD6140

90 mg tablet taken by mouth 2 times a day for 21 days per cycle

Active Comparator: 2

Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)

1 tablet taken by mouth once a day for 28 days per cycle

Other Names:

Nordette®

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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