MedDataX Logo

AZD6140 Oral Contraceptive Interaction Study

NCT ID: NCT00685906

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

oral contraceptive birth control Healthy volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

AZD6140

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Levonorgestrel and Ethinyl Estradiol (Nordette®)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD6140

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

Intervention Type DRUG

Levonorgestrel and Ethinyl Estradiol (Nordette®)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nordette®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kathleen Butler, MD

Role: STUDY_DIRECTOR

AstraZeneca

Audrey, Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

SeaView Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Miami, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AZD6140/OC Study

Identifier Type: -

Identifier Source: secondary_id

D5130C00042

Identifier Type: -

Identifier Source: org_study_id