AZD6140 Oral Contraceptive Interaction Study

Condition(s) targeted: Healthy

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

Phase: Phase 1

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Kathleen Butler, MD, Study Director, Affiliation: AstraZeneca
Audrey , Martinez, MD, Principal Investigator, Affiliation: SeaView Research

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

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: 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 design: Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®

Secondary outcome:

Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®

Blood levels of AZD6140 and its main metabolite after concomitant oral administration of AZD6140 and Nordette®

Safety and tolerability of AZD6140 when co-administered with Nordette®

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, Miami, Florida, United States; Recruiting

Starting date: April 2008
Ending date: February 2009
Last updated: May 28, 2008