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Completed

NCT Number: NCT00685906

AZD6140 Oral Contraceptive Interaction Study

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD6140

Drug

90 mg tablet taken by mouth 2 times a day for 21 days per cycle

Levonorgestrel and Ethinyl Estradiol (Nordette®)

Drug

1 tablet taken by mouth once a day for 28 days per cycle

Other names: Nordette®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

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

    Time frame: Screening through completion of the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 29, 2008
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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