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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01110525
First received: April 1, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Oral Contraceptives
Drug: AZD1981
Drug: Neovletta 21/28
Drug: Placebo AZD1981
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1981 + Oral contraceptive
Drug: AZD1981
4X100 mg per oral, twice daily for 28 days
Drug: Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
Other Name: Neovletta 21/28
Placebo Comparator: 2
Placebo + Oral contraceptive
Drug: Neovletta 21/28
Once daily with (21) or without (28) pause for bleeding.
Other Name: Neovletta 21/28
Drug: Placebo AZD1981
4X100 mg per oral, twice daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110525

Locations
Sweden
Research Site
Lulea, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva S Pettersson AstraZeneca R&D
Principal Investigator: Wolfgang Kühn Quintiles AB, Phase I Services
Principal Investigator: Aslak Rautio Quintiles Hermelinen AB
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01110525     History of Changes
Other Study ID Numbers: D9830C00015, 2010-018864-18
Study First Received: April 1, 2010
Last Updated: November 17, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Phase I
Drug-drug interaction
Oral contraceptives
AZD 1981

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 18, 2014