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Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects

Sponsor
AstraZeneca (Industry)
Overall Status
Suspended
CT.gov ID
NCT00901290
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
4
Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN, a monophasic oral contraceptive

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Official Title:
A Randomized, Open-Label, Two-way Crossover Study to Determine the Effects of Co-administration of AZD7325 and a Monophasic Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
Sep 1, 2009
Anticipated Study Completion Date :
Sep 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

monophasic oral contraceptive

Drug: monophasic oral contraceptive
mg, oral dose
Other Names:
  • ORTHO-CYCLEN

    		•
    Experimental: 2

    AZD7325

    Drug: AZD7325
    mg, oral dose

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the effect of repeated doses of AZD7325 on the pharmacokinetics of ORTHO-CYCLEN [weekly]

    Secondary Outcome Measures

    1. Characterize the pharmacokinetics of progesterone, luteinizing hormone, follicle-stimulating hormone, and sex hormone binding globulin following dosing with monophasic oral contraceptive (ORTH-CYCLEN) alone and following co-administration with AZD7325 [weekly]

    2. To characterize the steady-state pharmacokinetics of AZD7325 [weekly]

    3. To examine the safety and tolerability of AZD7325 in combination with the monophasic oral contraceptive (ORTHO-CYCLEN) [weekly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • If previously pregnant, must be > 6 month post-partum at the time of randomization

    • Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m2

    Exclusion Criteria:

    • Use of any prescription medication within 14 days of screening

    • current smoker or history of smoking within the last 3 months prior to enrollment

    • Abnormal pap smear exam result within one year of enrollment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Overland Park Kansas United States

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Principal Investigator: Eleanor Lisbon, MD, MPH, Quintiles Phase I Services

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00901290
    Other Study ID Numbers:
    • D1140C00018
    First Posted:
    May 13, 2009
    Last Update Posted:
    Dec 10, 2010
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    oral contraceptive
    Additional relevant MeSH terms:
    Contraceptive Agents
    Contraceptives, Oral

    Study Results

    No Results Posted as of Dec 10, 2010