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NCT02817464 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
A Phase 1 study of Pregnancy and Contraception, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT02817464 is a Phase 1 study of Pregnancy and Contraception that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 12 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT02817464, a Phase 1 study of Pregnancy and Contraception, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG TV-46046 - 400 mg/mL
- DRUG TV-46046 - 200 mg/mL
Study Locations (2)
Pennsylvania
- Teva Investigational Site 001 - Philadelphia
Virginia
- Teva Investigational Site 002 - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-10-26 |
| Est. Completion | 2018-12-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02817464
The ClinicalTrials.gov registry entry for NCT02817464 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (99% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which TV-46046 - 400 mg/mL is the first listed.
NCT02817464 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT02817464 about?
NCT02817464 is a clinical study titled "Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle". 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.
What is the current status of trial NCT02817464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2016-10-26. Estimated completion is 2018-12-03.
What conditions does trial NCT02817464 study?
This clinical trial studies the following conditions: Pregnancy, Contraception.
What interventions are being tested in trial NCT02817464?
The interventions under investigation include: TV-46046 - 400 mg/mL (DRUG), TV-46046 - 200 mg/mL (DRUG).
Who is sponsoring clinical trial NCT02817464?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02817464 being conducted?
This trial has 2 study locations across Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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