NCT01110525CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of of EE and LNG by analysis of the AUC and Css,max.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
1
Experimental
AZD1981 + Oral contraceptive
Intervention: AZD1981 (Drug)
1
Experimental
AZD1981 + Oral contraceptive
Intervention: Neovletta 21/28 (Drug)
2
Placebo Comparator
Placebo + Oral contraceptive
Intervention: Neovletta 21/28 (Drug)
2
Placebo Comparator
Placebo + Oral contraceptive
Intervention: Placebo AZD1981 (Drug)
Outcomes
Primary Outcomes
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
- 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.)
Investigators
Study Sites (1)
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