AZD6140 Oral Contraceptive Interaction Study

December 1, 2010 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD6140
90 mg tablet taken by mouth 2 times a day for 21 days per cycle
Active Comparator: 2
Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®)
1 tablet taken by mouth once a day for 28 days per cycle
Other Names:
  • Nordette®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of ethinyl estradiol, a female hormone, following oral administration of AZD6140 and Nordette®
Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood levels of various other hormones following concomitant oral administration of AZD6140 and Nordette®
Time Frame: At scheduled times following dosing during the first 3 weeks of menstrual cycles 1 and 2.
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®
Time Frame: At scheduled times following dosing during the first 3 weeks of Cycles 1 and 2.
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®
Time Frame: Screening through completion of the study
Screening through completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Audrey, Martinez, MD, SeaView Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

December 1, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130C00042
  • AZD6140/OC Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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