AZD6140 Oral Contraceptive Interaction Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®); Drug: AZD6140

Study type: Interventional

Funder types: Industry

Identifiers

NCT00685906

D5130C00042

AZD6140/OC Study

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: AZD6140

2

Active Comparator group

Treatment:

Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)