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

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.

Conditions

• Endometriosis

Interventions

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

Sponsors & Collaborators

• Parexel

  collaborator INDUSTRY

• Syneos Health

  collaborator OTHER

• Enteris BioPharma Inc.

  lead INDUSTRY

Principal Investigators

• Gary A. Shangold, M.D. · Enteris BioPharma Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-18

Primary Completion

2022-05-31

Completion

2022-05-31

FDA Drug

Yes

Countries

• United States

Study Locations