NCT05096065

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

An Open-label Dose-finding Study to Evaluate the Pharmacodynamic (PD) Profiles and Efficacy of Different Dosing Regimens of Leuprolide Oral Tablets (Ovarest®) in Women With Endometriosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Enteris BioPharma Inc. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The pharmacodynamic endpoint of percentage of subjects with suppressed estradiol level (less than 20 pg/mL) on cycle day 29 is the primary endpoint of the study.

Detailed description

Objectives of this study: 1. To determine efficacy and pharmacodynamic effects of various dosing regimens of Ovarest® (within the 60-mg - 120 mg daily dosing range) in women with endometriosis. 2. To determine a minimally effective daily dosing regimen of Ovarest® with pharmacodynamic effects at least comparable to the historical data for marketed Lupron Depot formulations and for GnRH antagonists indicated for the treatment of endometriosis. 3. To evaluate safety and tolerability of the long-term administration of leuprolide within the targeted daily dosing range in women with endometriosis. The most important goal of this study is to provide adequate dose-response data for the suppression of estradiol (E2) levels below the menopausal threshold of 20 pg/mL. Results of this study in conjunction of Enteris proprietary PK data will support further development of Leuprolide Acetate Oral Tablet for the treatment of reproductive disorders, particularly endometriosis. Another reason for this trial is to support a comparative evaluation of the PD effects across the QD and BID regimens delivering the same overall dose of Ovarest

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Leuprolide Oral Tablet - 120 mg - QD- Treatment A	If the subject during Treatment "A" meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of the First Treatment Cycle), in the Second Treatment Cycle, she will be assigned Treatment "B" - 80 mg (2 x 40 mg tablets) (QD), with food-intake restrictions. If the subject during Treatment "A" fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the First Treatment Cycle), then she will be switched to the Second Treatment Cycle with Treatment "D" - 60 mg (BID) with food intake restrictions.
DRUG	Leuprolide Oral Tablet - 80 mg - QD - Treatment B	If the subject on Treatment "B" meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "C" - 60 mg (QD) with food-intake restrictions. If the subject on Treatment "B" does not meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "E" - 40 mg (BID) with food intake restrictions.
DRUG	Leuprolide Oral Tablet - 60 mg - QD - Treatment C	For up to 29 consecutive days with food-intake restrictions
DRUG	Leuprolide Oral Tablet - 60 mg - BID - Treatment D	If the subject on Treatment "D" fails to meet the pharmacodynamic success criterion (i.e., if estradiol level ≥20 pg/mL on Treatment Day 29 of the Second Treatment Cycle), she will be discontinued from the study following completion of the Second Treatment Cycle. If the subject during Treatment "D" meets the pharmacodynamic success criterion (estradiol level \<20 pg/mL on Treatment Day 29 of her Second Treatment Cycle), then she will be switched to the Third Treatment Cycle with Treatment "E" - 40 mg (BID) with food intake restrictions.
DRUG	Leuprolide Oral Tablet - 40 mg - BID - Treatment E	For up to 29 consecutive days with food-intake restrictions

Timeline

• Start date: 2022-03-18
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-10-27
• Last updated: 2022-03-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study