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A Drug-drug Interaction Study to Investigate the Effects of AZD1981 on the Metabolism and Pharmacodynamics of Oral Contraceptives

NCT01110525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2010-11-18

No results posted yet for this study

Summary

The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the metabolism of hormones included in oral contraceptives.

Conditions

  • Oral Contraceptives

Interventions

DRUG

AZD1981

4X100 mg per oral, twice daily for 28 days

DRUG

Neovletta 21/28

Once daily with (21) or without (28) pause for bleeding.

DRUG

Placebo AZD1981

4X100 mg per oral, twice daily for 28 days

Sponsors & Collaborators

Principal Investigators

  • Eva S Pettersson · AstraZeneca R&D

  • Wolfgang Kühn · Quintiles AB, Phase I Services

  • Aslak Rautio · Quintiles Hermelinen AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01110525 on ClinicalTrials.gov