AZD6140 Oral Contraceptive Interaction Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00685906

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 I

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

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Levonorgestrel Estradiol valerate Estradiol acetate

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Safety and tolerability of AZD6140 when co-administered with Nordette® [ Time Frame: Screening through completion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD6140 90 mg tablet taken by mouth 2 times a day for 21 days per cycle
2: Active Comparator	Drug: Levonorgestrel and Ethinyl Estradiol (Nordette®) 1 tablet taken by mouth once a day for 28 days per cycle

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Jay Horrow, MD, Medical Science Director, AZD6140 )
Study ID Numbers:	D5130C00042, AZD6140/OC Study
Study First Received:	May 27, 2008
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00685906 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

oral contraceptive
birth control
Healthy volunteers

Additional relevant MeSH terms:

Contraceptives, Postcoital, Synthetic
Estrogens
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents

Contraceptives, Postcoital
Hormones
Estradiol
Pharmacologic Actions
Contraceptives, Oral, Combined
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic
Ethinyl Estradiol-Norgestrel Combination

ClinicalTrials.gov processed this record on November 05, 2009