Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis

Phase 2

Waitlist Available

Research Sponsored by Enteris BioPharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment days: 1,8, 15, 22 and 29; post dosing day 14

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an oral medication called Ovarest® for women with endometriosis. It aims to find the right dose that effectively lowers estradiol levels to help manage symptoms. The study also evaluates the long-term safety of the medication.

Eligible Conditions

Endometriosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment days: 1,8, 15, 22 and 29; post dosing day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment days: 1,8, 15, 22 and 29; post dosing day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment days: 1,8, 15, 22 and 29; post dosing day 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL

Secondary study objectives

(Pre-dose leuprolide level) Subject incidence of Leuprolide below detectable level

Composite Pelvic Signs and Symptoms (CPSS) scores

Follicle Stimulating Hormone (FSH) levels

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Treatment E:Leuprolide Oral Tablet (Ovarest), 40 mg BIDExperimental Treatment1 Intervention

Leuprolide Oral Tablet (Ovarest), 40 mg, administered twice daily (BID), 12 hours apart for up to 29 consecutive days with food-intake restrictions.

Group II: Treatment D: Leuprolide Oral Tablet, 60 mg BIDExperimental Treatment1 Intervention

Leuprolide Oral Tablet (Ovarest), 60 mg, administered twice daily (BID), 12 hours apart for up to 35 consecutive days with food-intake restrictions.

Group III: Treatment C: Leuprolide Oral Tablet, 60 mg QDExperimental Treatment1 Intervention

Leuprolide Oral Tablet (Ovarest), 60 mg, administered once daily (QD) for up to 29 consecutive days with food-intake restrictions.

Group IV: Treatment B: Leuprolide Oral Tablet, 80 mg QDExperimental Treatment1 Intervention

Leuprolide Oral Tablet (Ovarest), 80 mg (2 x 40 mg tablets), administered once daily (QD) for up to 35 consecutive days with food-intake restrictions.

Group V: Treatment A: Leuprolide Oral Tablet, 120 mg QDExperimental Treatment1 Intervention

Leuprolide Oral Tablet (Ovarest), 120 mg (2 x 60 mg tablets), administered once daily (QD), for up to 35 consecutive days with food-intake restrictions.

Do I qualify?Apply below to find out