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NCT04682353 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
A Phase 1 study of Contraception, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT04682353: Completed Phase 1 study of Contraception, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT04682353 is a Phase 1 study of Contraception that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 60 participants, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (87% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04682353, a Phase 1 study of Contraception, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The secondary objectives of the study are to evaluate and compare the safety, local tolerability, and acceptability of a subcutaneous injection of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The total duration of the study for each participant is expected to be up to 19.5 months.
Conditions Studied
Interventions
- DRUG TV-46046
- DRUG Depo-subQ Provera
Study Locations (3)
California
- Teva Investigational Site 14002 - Cypress
Texas
- Teva Investigational Site 14003 - San Antonio
Other
- Teva Investigational Site 18001 - Santo Domingo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2023-01-12 |
| Phase | Phase 1 |
What the finished NCT04682353 record still lists
NCT04682353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 2 interventions - of which TV-46046 is the first listed.
NCT04682353 reports a single indexed study location in California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT04682353 about?
NCT04682353 is a clinical study titled "A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age". The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in healthy female participants. The secondary objectives of the study are ...
What is the current status of trial NCT04682353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-12-14. Estimated completion is 2023-01-12.
What conditions does trial NCT04682353 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT04682353?
The interventions under investigation include: TV-46046 (DRUG), Depo-subQ Provera (DRUG).
Who is sponsoring clinical trial NCT04682353?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04682353 being conducted?
This trial has 3 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04682353's enrollment target sits among peer trials
60 48th of 72 higher than 25 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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