We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

AZD6140 Oral Contraceptive Interaction Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685906
First Posted: May 29, 2008
Last Update Posted: December 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Healthy Drug: AZD6140 Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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. ]
  • 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. ]
  • Safety and tolerability of AZD6140 when co-administered with Nordette® [ Time Frame: Screening through completion of the study ]

Estimated Enrollment: 24
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nordette®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685906


Locations
United States, Florida
Research Site
Miami, Florida, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Kathleen Butler, MD AstraZeneca
Principal Investigator: Audrey , Martinez, MD SeaView Research
  More Information

Responsible Party: Jay Horrow, MD, Medical Science Director, AZD6140, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00685906     History of Changes
Other Study ID Numbers: D5130C00042
AZD6140/OC Study
First Submitted: May 27, 2008
First Posted: May 29, 2008
Last Update Posted: December 2, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
oral contraceptive
birth control
Healthy volunteers

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Ticagrelor
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital