The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
12
A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL
A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL
Teva Investigational Site 001
Philadelphia, Pennsylvania, United States
Teva Investigational Site 002
Norfolk, Virginia, United States
Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Time frame: Day 1
Part 1: Serum MPA Concentration at Day 7
Time frame: Day 7
Part 1: Serum MPA Concentration at Day 28
Time frame: Day 28
Part 1: Serum MPA Concentration at Day 91
Time frame: Day 91
Part 1: Serum MPA Concentration at Day 182
Time frame: Day 182
Part 1: Serum MPA Concentration at Day 210
Time frame: Day 210
Part 1: Maximum Observed Serum Concentration (Cmax) of MPA
Time frame: Day 0 up to Week 52
Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA
Time frame: Day 182
Part 1: Time to Reach Cmax (Tmax) of MPA
Time frame: Day 0 up to Week 52
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
Time frame: Day 0 up to Day 182
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
Time frame: Day 0 up to Day 210
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Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA
Time frame: Day 0 up to Week 52
Part 1: Apparent Terminal Half-life (t1/2) of MPA
Time frame: Day 0 up to Week 52
Part 2: Time to Ovulation
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
Time frame: Day 0 up to Week 78
Part 1: Time to Ovulation
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.
Time frame: Day 0 up to Week 78
Part 2: Cmax of MPA
Time frame: Day 0 up to Week 52
Part 2: Tmax of MPA
Time frame: Day 0 up to Week 52
Part 2: Observed Serum Drug Concentration at Day 210 (C210) of MPA
Time frame: Day 0 up to Day 210
Part 2: C182 of MPA
Time frame: Day 0 up to Day 182
Part 2: AUC0-182 of MPA
Time frame: Day 0 up to Day 182
Part 2: AUC0-210 of MPA
Time frame: Day 0 up to Day 210
Part 2: AUC0-∞ of MPA
Time frame: Day 0 up to Week 52
Part 2: Apparent Terminal Half Life (t1/2) of MPA
Time frame: Day 0 up to Week 52
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Time frame: Day 0 up to Week 78