Study

A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenon

The main purpose of this clinical research study is to learn the effect of LF111 tablet and DRSP 3.5 mg chewable tablet (USA only) on estradiol levels in the blood and on BMD, and to see if we can rule out (not worry about) potential impact on BMD in female adolescents and potential risks of age-related loss of bone mass in female adults comparted to non-hormonal birth-control.

Why this Research Matters

Approximately 1700 adolescents and adults will take part in this study at approximately 40 study sites in US and Europe. Participants in the USA who choose to use a hormonal contraceptive method will have an opportunity to use the LF111 tablets or the DRSP 3.5 mg chewable tablets. Approximately 120 participants in the hormonal treatment arm in the USA should receive DRSP 3.5 mg chewable tablets. The DRSP 3.5 mg chewable tablets are not available to subjects in Europe. Your participation in this study will last approximately 14 to 26 months depending on your BMD results and will include approximately 4-6 study visits to the study site and 4 phone calls. Your study investigator will let you know when and how many times you need to come to the study site.