MedTrace Logo

A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers

NCT02807363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-02-11

Study results available
· View outcomes & findings →

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.

Conditions

  • Endometriosis

Interventions

DRUG

Leuprolide Oral Tablet 4-mg QD

4-mg Leuprolide oral tablet once daily for 28 consecutive days.

DRUG

Leuprolide Oral Tablet 4-mg BID

4-mg Leuprolide oral tablet twice daily for 28 consecutive days.

DRUG

Leuprolide Depot

3.75 mg intramuscular depot injection

DRUG

Leuprolide Oral Tablet 10-mg BID

10-mg Leuprolide oral tablet twice daily for 28 consecutive days.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Enteris BioPharma Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Shangold, MD · Enteris BioPharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-06-27
Completion
2018-06-27
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807363 on ClinicalTrials.gov