AZD6140 Oral Contraceptive Interaction Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD6140; Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)

• Registration Number: NCT00685906
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD6140	-
2	Levonorgestrel and Ethinyl Estradiol (Nordette®)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Miami, Florida, United States