AZD6140 Oral Contraceptive Interaction Study

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Ethinyl Estradiol-Norgestrel Combination; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate; Ticagrelor

Criteria

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