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

Phase 1

Completed

• Conditions: Oral Contraceptives
• Interventions: Drug: AZD1981; Drug: Neovletta 21/28; Drug: Placebo AZD1981

• Registration Number: NCT01110525
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-17
• Last Update Posted: 2010-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1981	AZD1981 + Oral contraceptive
1	Neovletta 21/28	AZD1981 + Oral contraceptive
2	Neovletta 21/28	Placebo + Oral contraceptive
2	Placebo AZD1981	Placebo + Oral contraceptive

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden