A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
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ClinicalTrials.gov Identifier: NCT02807363 |
Recruitment Status :
Completed
First Posted : June 21, 2016
Results First Posted : February 11, 2022
Last Update Posted : February 11, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Endometriosis |
Interventions |
Drug: Leuprolide Oral Tablet 4-mg QD Drug: Leuprolide Oral Tablet 4-mg BID Drug: Leuprolide Depot Drug: Leuprolide Oral Tablet 10-mg BID |
Enrollment | 35 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Leuprolide Oral Tablet, 4 mg QD (Treatment A) | Leuprolide Oral Tablet, 4 mg BID (Treatment B) | Leuprolide 1 Month Depot (Treatment C) | Leuprolide Oral Tablet, 10 mg BID (Treatment D) |
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Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days. Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days. |
Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days. Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days. |
Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy Leuprolide Depot: 3.75 mg intramuscular depot injection |
Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days. |
Period Title: Dosing Period | ||||
Started | 9 | 9 | 5 | 12 |
Completed | 9 | 8 | 5 | 12 |
Not Completed | 0 | 1 | 0 | 0 |
Reason Not Completed | ||||
Adverse Event | 0 | 1 | 0 | 0 |
Period Title: Post- Dosing Period | ||||
Started | 9 | 8 | 5 | 12 |
Completed | 9 | 8 | 5 | 12 |
Not Completed | 0 | 0 | 0 | 0 |
Arm/Group Title | Leuprolide Oral Tablet, 4 mg QD (Treatment A) | Leuprolide Oral Tablet, 4 mg BID (Treatment B) | Leuprolide 1 Month Depot (Treatment C) | Leuprolide Oral Tablet, 10 mg BID (Treatment D) | Total | |
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Leuprolide Oral Tablet QD: 4 mg for 28 consecutive days. Leuprolide Oral Tablet 4-mg QD: 4-mg Leuprolide oral tablet once daily for 28 consecutive days. |
Leuprolide Oral Tablet BID: 4 mg, 12 hours apart for 28 consecutive days. Leuprolide Oral Tablet 4-mg BID: 4-mg oral tablet twice daily for 28 consecutive days. |
Leuprolide Depot : intramuscular (IM) 3.75 mg depot injection administered for one month of therapy Leuprolide Depot: 3.75 mg intramuscular depot injection |
Leuprolide Oral Tablet BID: 10 mg, 12 hours apart for 28 consecutive days Leuprolide Oral Tablet 10-mg BID: 10-mg oral tablet twice daily for 28 consecutive days. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 9 | 9 | 5 | 12 | 35 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
38.4 (6.1) | 38.4 (5.9) | 37.8 (6.6) | 37.2 (4.9) | 37.9 (5.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
Female | 9 | 9 | 5 | 12 | 35 | |
Male | 0 | 0 | 0 | 0 | 0 | |
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
Hispanic or Latino |
3 33.3%
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0 0.0%
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1 20.0%
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1 8.3%
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5 14.3%
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Not Hispanic or Latino |
6 66.7%
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9 100.0%
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4 80.0%
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11 91.7%
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30 85.7%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 11.1%
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0 0.0%
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0 0.0%
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2 16.7%
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3 8.6%
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White |
8 88.9%
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9 100.0%
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5 100.0%
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10 83.3%
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32 91.4%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Height
Mean (Standard Deviation) Unit of measure: Inches |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
63.93 (2.14) | 63.60 (1.10) | 65.28 (2.69) | 64.05 (2.15) | 64.1 (2.0) | ||
Body Mass Index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
25.734 (3.292) | 26.054 (3.262) | 24.242 (3.255) | 24.988 (3.235) | 25.3 (3.2) | ||
Weight
Mean (Standard Deviation) Unit of measure: Lbs |
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Number Analyzed | 9 participants | 9 participants | 5 participants | 12 participants | 35 participants | |
149.41 (22.36) | 149.63 (20.63) | 147.40 (17.47) | 146.64 (22.38) | 148.15 (20.4) |
Name/Title: | Paul Shields, Ph.D |
Organization: | Enteris Biopharma Inc. |
Phone: | 9734533520 |
EMail: | pshields@enterisbiopharma.com |
Responsible Party: | Enteris BioPharma Inc. |
ClinicalTrials.gov Identifier: | NCT02807363 |
Other Study ID Numbers: |
LOPDT-ENDO-01 |
First Submitted: | June 14, 2016 |
First Posted: | June 21, 2016 |
Results First Submitted: | October 27, 2021 |
Results First Posted: | February 11, 2022 |
Last Update Posted: | February 11, 2022 |