A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives
NCT ID: NCT01110525
Last Updated: 2010-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2010-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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1
AZD1981 + Oral contraceptive
AZD1981
4X100 mg per oral, twice daily for 28 days
Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
2
Placebo + Oral contraceptive
Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
Placebo AZD1981
4X100 mg per oral, twice daily for 28 days
Interventions
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AZD1981
4X100 mg per oral, twice daily for 28 days
Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
Placebo AZD1981
4X100 mg per oral, twice daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* Use of Neovletta or Neovletta 28 minimum 3 months prior to enrolment.
* Willing to use a highly effective method of birth control, ie, double barrier method contraception.
Exclusion Criteria
* Any clinically significant disease or disorder.
* Any clinically relevant abnormal findings in physical examination.
18 Years
45 Years
FEMALE
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Eva S Pettersson
Role: STUDY_DIRECTOR
AstraZeneca R&D
Wolfgang Kühn
Role: PRINCIPAL_INVESTIGATOR
Quintiles AB, Phase I Services
Aslak Rautio
Role: PRINCIPAL_INVESTIGATOR
Quintiles Hermelinen AB
Locations
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Research Site
Luleå, , Sweden
Research Site
Uppsala, , Sweden
Countries
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Other Identifiers
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2010-018864-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D9830C00015
Identifier Type: -
Identifier Source: org_study_id