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

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

August 23, 2017

Primary Completion Date

June 27, 2018

Study Completion Date

June 27, 2018

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.

Trial Locations (1)

G1P 0A2

inVentiv Health Clinique, Inc., Québec

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Enteris BioPharma Inc.

INDUSTRY