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

Keywords

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

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study arms

• Experimental
  1

  AZD1981 + Oral contraceptive

  Drug: AZD1981 · Drug: Neovletta 21/28

• Placebo comparator
  2

  Placebo + Oral contraceptive

  Drug: Neovletta 21/28 · Drug: Placebo AZD1981

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

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.