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Completed

NCT Number: NCT01110525

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

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

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Key information

Conditions

Oral Contraceptives

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Luleå, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1981

Drug

4X100 mg per oral, twice daily for 28 days

Neovletta 21/28

Drug

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

Placebo AZD1981

Drug

4X100 mg per oral, twice daily for 28 days

Primary outcomes

  1. 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

  1. 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.

  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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2010
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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