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
2 other identifiers
interventional
28
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2010
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 18, 2010
November 1, 2010
5 months
April 1, 2010
November 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Study Arms (2)
1
EXPERIMENTALAZD1981 + Oral contraceptive
2
PLACEBO COMPARATORPlacebo + Oral contraceptive
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Luleå, Sweden
Research Site
Uppsala, Sweden
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Eva S Pettersson
AstraZeneca R&D
- PRINCIPAL INVESTIGATOR
Wolfgang Kühn
Quintiles AB, Phase I Services
- PRINCIPAL INVESTIGATOR
Aslak Rautio
Quintiles Hermelinen AB
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 26, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 18, 2010
Record last verified: 2010-11