At a glance
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A Randomized, Open-label, Parallel-group, Active-control PK/PD Study of Three Doses of Leuprolide Oral Tablets in Comparison to an IM Dose of Leuprolide in Healthy Female Volunteers
In Brief
A Phase 2 clinical trial evaluating Leuprolide Oral Tablet 4-mg QD, Leuprolide Oral Tablet 4-mg BID, and 2 other interventions for Endometriosis. Completed, enrolled 35 participants across 1 site.
Detailed Summary
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and cessation of the menstrual period) will also be evaluated against the Lupron Depot historical data.
Study Details
Timeline
Interventions
4-mg Leuprolide oral tablet once daily for 28 consecutive days.
4-mg Leuprolide oral tablet twice daily for 28 consecutive days.
3.75 mg intramuscular depot injection
10-mg Leuprolide oral tablet twice daily for 28 consecutive days.