A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at
      steady state on the steady state pharmacokinetic profile of ethinyl estradiol and
      norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state
      ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will
      assess the safety and tolerability of concurrent use of colchicine and an
      estrogen/progesterone-containing oral contraceptive.
    

Detailed description: 
      This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at
      steady state on the steady state pharmacokinetic profile of ethinyl estradiol and
      norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady state
      ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this study will
      assess the safety and tolerability of concurrent use of colchicine and an
      estrogen/progesterone-containing oral contraceptive. Following an optional single cycle
      run-in period in which subjects taking other oral contraceptives are switched to Ortho-Novum
      1/35, 30 healthy adult female volunteers of child bearing age (18-45 years old) will be
      randomized in a double blind crossover fashion to receive each of two ethinyl estradiol and
      norethindrone dosing regimens in sequence. During each of the two dosing periods, subjects
      will receive one ethinyl estradiol and norethindrone tablet on the mornings of Days 1-7 of
      their cycles. On days 8-21, subjects will receive twice daily doses of either colchicine (0.6
      mg capsule twice daily with breakfast and dinner) or the placebo (one capsule twice daily
      with breakfast and dinner), according to their randomization schedule, along with one ethinyl
      estradiol and norethindrone tablet. Subjects will receive the alternate dosing regimen in
      Cycle 2. Blood samples will be drawn at times sufficient to determine the steady state
      pharmacokinetics of ethinyl estradiol and norethindrone with and without steady state
      colchicine. In addition, during the cycle in which active colchicine is given, the effect of
      steady state ethinyl estradiol and norethindrone on steady state colchicine will be
      evaluated. Subjects will be monitored for adverse effects throughout the study via query and
      spontaneous reporting. Additionally baseline 12 lead EKG and vital signs will be compared to
      those obtained at time points throughout the study period.
    

Intervention name(s): Norethindrone/Ethinyl Estradiol; Colchicine; Placebo (for Colchicine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): one tablet daily - 1 mg norethindrone/0.035 mg ethinyl estradiol on Days 1 to 21; inert ingredients on Days 22 to 28; 0.6mg tablet every 12 hours on Days 8 to 21; placebo tablet every 12 hours on Days 8 to 21
Other intervention name(s): COLCRYS TM
Intervention MeSH terms: Colchicine; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: healthy; pharmacokinetics; drug-interaction