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

AstraZeneca1 site in 1 country28 target enrollmentMay 2010

ConditionsOral Contraceptives

InterventionsAZD1981 Neovletta 21/28 Placebo AZD1981

DrugsAZD1981 Neovletta 21/28 Placebo AZD1981

Overview

Phase: Phase 1
Intervention: AZD1981
Conditions: Oral Contraceptives
Sponsor: AstraZeneca
Enrollment: 28
Locations: 1
Primary Endpoint: Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

October 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

1

AZD1981 + Oral contraceptive

Intervention: AZD1981

1

AZD1981 + Oral contraceptive

Intervention: Neovletta 21/28

2

Placebo + Oral contraceptive

Intervention: Neovletta 21/28

2

Placebo + Oral contraceptive

Intervention: Placebo AZD1981

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Effect on LH, FSH, SHBG, progesterone, and E2 during the menstrual cycle: Serum concentrations of LH, FSH, SHBG, progesterone and E2(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(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.(PK-sampling of AZD1981 wil be done at the end of treatment period 1 and 2.)