Bioavailability study comparing MP0008 (Femlyv) and Charlotte 24 Fe without water

• Research type

  Research Study

• Full title

  An Open-Label, Randomised, 2-Period, 2-Way Crossover Study to Evaluate the Relative Bioavailability of Norethindrone and Ethinyl Estradiol Administered (Without Water) as an MP0008 (Femlyv™) Orally Disintegrating Tablet to that of a Charlotte® 24 Fe Chewable Tablet in Healthy Adult Female Participants

• IRAS ID

  1011728

• Contact name

  Ilka Schellschmidt

• Contact email

  ilka.schellschmidt@millicentpharma.com

• Sponsor organisation

  Millicent Puerto Rico LLC

• ISRCTN Number

  ISRCTN23370352

• Research summary

  This study compares two different forms of a contraceptive pill taken without water: Femlyv™ (an orally disintegrating tablet) and Charlotte® 24 Fe (a chewable tablet). Both are FDA-approved for pregnancy prevention and contain the same active ingredients: Norethindrone Acetate (1 mg) Ethinyl Estradiol (20 mcg). We will take blood samples to measure how much of these hormones enter the bloodstream after a single dose of each pill. The study is particularly interested in understanding how the restriction of water will impact the levels of hormones in the blood. Participants will take both treatments at different times (in a crossover design), meaning each person will try both pills. This helps ensure accurate comparisons. The study will require two 2-night stays (3 days) with 2 return visits in each period.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  25/EE/0060

• Date of REC Opinion

  2 Apr 2025

• REC opinion

  Further Information Favourable Opinion