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AZD6140 Oral Contraceptive Interaction Study

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

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

Phase: Phase 1

Status: Completed

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

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

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

Secondary outcome:

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

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

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

Eligibility

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 NordetteĀ® 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

Locations and Contacts

Research Site, Miami, Florida, United States
Additional Information

Starting date: April 2008
Last updated: December 1, 2010

Page last updated: August 23, 2015

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