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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110525

Enrollment

Registered

2010-04-26

Start date

2010-05-31

Completion date

2010-10-31

Last updated

2010-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Contraceptives

Keywords

Phase I, Drug-drug interaction, Oral contraceptives, AZD 1981

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.

Interventions

DRUGAZD1981

4X100 mg per oral, twice daily for 28 days

DRUGNeovletta 21/28

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

DRUGPlacebo AZD1981

4X100 mg per oral, twice daily for 28 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026