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

Oral Contraceptives Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110525
• Other study ID #: D9830C00015
• Secondary ID: 2010-018864-18
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2010
• Last updated: November 17, 2010
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Oral Contraceptives

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Research Site	Lulea
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.		PK sampling will be performed regularly during the study period of two months.	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	Steady state PK of 1981 in combo with oral contraceptives AUCt, 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.	No