Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04682353
The ClinicalTrials.gov registry entry for NCT04682353 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (87% 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 1 condition, with Contraception appearing as the primary indexed condition, and to 2 interventions - of which TV-46046 is the first listed.
NCT04682353 reports 3 study locations spanning 3 distinct geographic areas - top geographies include 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
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
ORAL T-6: Oral Androgens in Man-6
COMPLETED · Phase 1
-
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
COMPLETED · Phase 1
-
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
COMPLETED · Phase 1
-
NES Gel-1, To Evaluate Nestorone Gel in Combination With Testosterone Gel
COMPLETED · Phase 1
-
Oral Contraceptive Pill (OCP) Pharmacogenomics
RECRUITING · Phase 4
-
Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement
RECRUITING · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.