At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
TV-46046 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 9, 2018·Updated Jan 26, 2022
In Brief
A Phase 1 clinical trial evaluating TV-46046, Depo-subQ 104, and 1 other intervention for Contraception. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesDominican Republic
CollaboratorsFHI 360
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartJan 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedOct 9, 2018
Enrollment StartJan 15, 2019
Primary CompletionOct 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago
Interventions
TV-46046drug
TV-46046 will be administered per dose and schedule specified in the arm.
Depo-subQ 104drug
Depo-subQ 104 will be administered per dose and schedule specified in the arm.
TV-46046 Placebodrug
TV-46046 Placebo will be administered per schedule specified in the arm.