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

November 17, 2010 updated by: AstraZeneca

A Phase I, Double-blind, Randomised, Placebo-controlled, Two-cycle Crossover, Drug-drug Interaction Study to Investigate the Effects of AZD1981 Tablets 400 mg Twice Daily on the PK and PD of Oral Contraceptives in Healthy Female Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lulea, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females of childbearing potential
  • 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:

  • Pregnancy and/or lactation or delivery/abortion within 6 months prior to randomisation.
  • Any clinically significant disease or disorder.
  • Any clinically relevant abnormal findings in physical examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AZD1981 + Oral contraceptive
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.
Placebo Comparator: 2
Placebo + Oral contraceptive
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Time Frame: PK sampling will be performed regularly during the study period of two months.
PK sampling will be performed regularly during the study period of two months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2
Time Frame: PD sampling will be done at the end of treatment period 1 and 2.
PD sampling will be done at the end of treatment period 1 and 2.
Safety and tolerability of the combination: Adverse events, safety laboratory variables, pulse, blood pressure, electrocardiogram and physical examinations
Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Steady state PK of 1981 in combo with oral contraceptives AUCτ, Css,max, time to Cmax during a dosing interval (tmax ss);apparent plasma clearance (CLss/F) of AZD1981(tmax ss) of EE and LNG; Morning Ctrough values of EE and LNG will be measured.
Time Frame: PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.
PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Eva S Pettersson, AstraZeneca R&D
  • Principal Investigator: Wolfgang Kühn, Quintiles AB, Phase I Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 23, 2010

First Posted (Estimate)

April 26, 2010

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D9830C00015
  • 2010-018864-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Contraceptives

Clinical Trials on AZD1981

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe