Trial Outcomes & Findings for A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers (NCT NCT02807363)

Last Updated: 2022-02-11

Results Overview

Criterion: E2 level is considered suppressed during the evaluation period if a value below pre-specified threshold was reported at least once during that period. The days in the row title indicate the evaluation interval.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Dosing Period: Day 8 to 28, Post-dosing: Day 1 to day 28 of post dosing period; Day 29 is the post dosing day 1

Results posted on

2022-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) 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, 4 mg BID (Treatment B) 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 1 Month Depot (Treatment C) 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, 10 mg BID (Treatment D) 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.
Dosing Period STARTED	9	9	5	12
Dosing Period COMPLETED	9	8	5	12
Dosing Period NOT COMPLETED	0	1	0	0
Post- Dosing Period STARTED	9	8	5	12
Post- Dosing Period COMPLETED	9	8	5	12
Post- Dosing Period NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) 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, 4 mg BID (Treatment B) 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 1 Month Depot (Treatment C) 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, 10 mg BID (Treatment D) 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.
Dosing Period Adverse Event	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 Participants 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, 4 mg BID (Treatment B) n=9 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) n=12 Participants 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 n=35 Participants Total of all reporting groups
Age, Continuous	38.4 years STANDARD_DEVIATION 6.1 • n=5 Participants	38.4 years STANDARD_DEVIATION 5.9 • n=7 Participants	37.8 years STANDARD_DEVIATION 6.6 • n=5 Participants	37.2 years STANDARD_DEVIATION 4.9 • n=4 Participants	37.9 years STANDARD_DEVIATION 5.5 • n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Height	63.93 inches STANDARD_DEVIATION 2.14 • n=5 Participants	63.60 inches STANDARD_DEVIATION 1.10 • n=7 Participants	65.28 inches STANDARD_DEVIATION 2.69 • n=5 Participants	64.05 inches STANDARD_DEVIATION 2.15 • n=4 Participants	64.1 inches STANDARD_DEVIATION 2.0 • n=21 Participants
Body Mass Index	25.734 kg/m^2 STANDARD_DEVIATION 3.292 • n=5 Participants	26.054 kg/m^2 STANDARD_DEVIATION 3.262 • n=7 Participants	24.242 kg/m^2 STANDARD_DEVIATION 3.255 • n=5 Participants	24.988 kg/m^2 STANDARD_DEVIATION 3.235 • n=4 Participants	25.3 kg/m^2 STANDARD_DEVIATION 3.2 • n=21 Participants
Weight	149.41 lbs STANDARD_DEVIATION 22.36 • n=5 Participants	149.63 lbs STANDARD_DEVIATION 20.63 • n=7 Participants	147.40 lbs STANDARD_DEVIATION 17.47 • n=5 Participants	146.64 lbs STANDARD_DEVIATION 22.38 • n=4 Participants	148.15 lbs STANDARD_DEVIATION 20.4 • n=21 Participants

PRIMARY outcome

Timeframe: Dosing Period: Day 8 to 28, Post-dosing: Day 1 to day 28 of post dosing period; Day 29 is the post dosing day 1

Outcome measures

Outcome measures
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 Participants 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, 4 mg BID (Treatment B) n=8 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) n=12 Participants 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.
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL Days 8,15, 22, 28 and 29	6 Participants	7 Participants	5 Participants	12 Participants
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL Days 15, 22, 28 and 29	5 Participants	7 Participants	5 Participants	12 Participants
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL Days 22, 28 and 29	4 Participants	6 Participants	5 Participants	9 Participants
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL Days 22 and 29	4 Participants	6 Participants	5 Participants	9 Participants
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL Entire 28-day Dosing Period	7 Participants	8 Participants	5 Participants	12 Participants
Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL 28-day Post-dosing Period	7 Participants	6 Participants	5 Participants	9 Participants

PRIMARY outcome

Timeframe: Dosing period: Day 1 to Day 28 and 28 day Post-Dosing Period; 29 day is post dosing day 1

Progesterone level is considered suppressed during the evaluation period if a value below pre-specified threshold (3000 pg/mL) was reported at least once during that period. The days in row title indicate the evaluation interval.

Outcome measures

Outcome measures
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 Participants 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, 4 mg BID (Treatment B) n=8 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) n=12 Participants 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.
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL Days 8, 15, 22, 28 and 29	4 Participants	3 Participants	3 Participants	10 Participants
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL Days 15, 22, 28 and 29	2 Participants	2 Participants	0 Participants	0 Participants
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL Days 22, 28 and 29	2 Participants	2 Participants	0 Participants	0 Participants
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL Days 22 and 29	2 Participants	1 Participants	0 Participants	0 Participants
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL Entire 28-day Dosing Period	8 Participants	5 Participants	4 Participants	12 Participants
Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL 28-day Post-dosing Period	9 Participants	7 Participants	2 Participants	12 Participants

PRIMARY outcome

Timeframe: Dosing Period: Day 1 to day 28

The participant incidence of TEAEs was generally comparable during the dosing period across the treatment groups. Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for adverse event was collected for day 1 to 28 of the dosing period.

Outcome measures

Outcome measures
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 Participants 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, 4 mg BID (Treatment B) n=9 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) n=12 Participants 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.
Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAE) Excluding Menstrual Disorders Number of subjects with at least one TEAE	7 Participants	9 Participants	4 Participants	8 Participants
Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAE) Excluding Menstrual Disorders Number of subjects who discontinued due to TEAE	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Post dosing period (starting day 1 to day 28 post dosing period)

Treatment C is a depot formulation established to release the drug over a period of 1 month. The data for post dosing adverse event was collected starting from day 1 to 28 post the 28th day of dosing.

Outcome measures

Outcome measures
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 Participants 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, 4 mg BID (Treatment B) n=8 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) n=12 Participants 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.
Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs), Excluding Menstrual Disorders Number of subjects with at least one TEAE	1 Participants	2 Participants	1 Participants	3 Participants
Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs), Excluding Menstrual Disorders Number of subject who discontinued due to TEAEs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Treatment Day 28 for oral groups; Treatment Days 22-29 for Lupron Depot group

Population: Treatment D: Css determination along with most other pharmacokinetic parameters was not done for this treatment arm as fewer blood samples were planned for this treatment arm.

Treatment A and B: Steady state concentration level calculated for oral tablets at the end of the fourth treatment week (Treatment Day 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e. 24 hours. Treatment C: Steady state concentration level calculated for IM injection at the fourth treatment week (a mean of leuprolide levels on Days 22 and 29).

Outcome measures

Outcome measures
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=8 Participants 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, 4 mg BID (Treatment B) n=8 Participants 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 1 Month Depot (Treatment C) n=5 Participants 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, 10 mg BID (Treatment D) 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.
Steady State Concentration Level, (Css) of Leuprolide	357.80 pg/mL Standard Deviation 367.37	688.27 pg/mL Standard Deviation 258.01	180.95 pg/mL Standard Deviation 101.04	—

Adverse Events

Leuprolide Oral Tablet, 4 mg QD (Treatment A)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Leuprolide Oral Tablet, 4 mg BID (Treatment B)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Leuprolide 1 Month Depot (Treatment C)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Leuprolide Oral Tablet, 10 mg BID (Treatment D)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Leuprolide Oral Tablet, 4 mg QD (Treatment A) n=9 participants at risk 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, 4 mg BID (Treatment B) n=9 participants at risk 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 1 Month Depot (Treatment C) n=5 participants at risk 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, 10 mg BID (Treatment D) n=12 participants at risk 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.
Nervous system disorders Headache, disturbance in attention, dizziness, presyncope	44.4% 4/9 • Number of events 6 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	88.9% 8/9 • Number of events 10 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	60.0% 3/5 • Number of events 3 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	33.3% 4/12 • Number of events 4 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Gastrointestinal disorders Nausea, Vomiting, Abdominal pain, abdominal pain upper, dry mouth, faeces soft	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	55.6% 5/9 • Number of events 6 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	20.0% 1/5 • Number of events 2 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	16.7% 2/12 • Number of events 5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Vascular disorders hot flush	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	33.3% 3/9 • Number of events 3 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	20.0% 1/5 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	25.0% 3/12 • Number of events 4 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Reproductive system and breast disorders Breast tenderness. Metrorrhagia,	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	33.3% 3/9 • Number of events 3 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	33.3% 4/12 • Number of events 4 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Skin and subcutaneous tissue disorders Acne, erythema	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	20.0% 1/5 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	8.3% 1/12 • Number of events 2 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Infections and infestations Nasopharyngitis, gastroenteritis, vaginitis gardnerella	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	20.0% 1/5 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	16.7% 2/12 • Number of events 2 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Respiratory, thoracic and mediastinal disorders Cough, Oropharyngeal pain	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	8.3% 1/12 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Psychiatric disorders Depressed mood, Insomnia	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	20.0% 1/5 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/12 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
General disorders Axillary pain	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	8.3% 1/12 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/12 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/9 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/5 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.	0.00% 0/12 • Dosing period (day 1 to day 28) and post dosing period (day 1 to day 28) Treatment C being a 1 month (28 day cycle) depot formulation is mentioned as a 1 month therapy but the adverse event monitoring was done for the same time frame as treatment A, B and D.

Additional Information

Paul Shields, Ph.D

Enteris Biopharma Inc.

Phone: 9734533520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place