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NCT05041699 · ClinicalTrials.gov registry record · Phase 1
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A Phase 1 study of Pharmacokinetics and Bleeding, sponsored by International Partnership for Microbicides.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT05041699: Completed Phase 1 study of Pharmacokinetics and Bleeding, sponsored by International Partnership for Microbicides.
NCT05041699 is a Phase 1 study of Pharmacokinetics and Bleeding that has completed, run by International Partnership for Microbicides. The registered enrollment target is 40 participants, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05041699, a Phase 1 study of Pharmacokinetics and Bleeding, has completed, sponsored by International Partnership for Microbicides.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
Primary Outcome
DPV and LNG concentrations in plasma
Conditions Studied
Interventions
- COMBINATION_PRODUCT IPM Ring-105
- COMBINATION_PRODUCT IPM Ring-106
Study Locations (2)
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- UPMC Magee-Womens Hospital, Center for Family Planning Research - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2024-10-07 |
| Phase | Phase 1 |
What the finished NCT05041699 record still lists
NCT05041699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 61-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (34% lower).
The record links to 3 conditions, with Pharmacokinetics appearing as the primary indexed condition, and to 2 interventions - of which IPM Ring-105 is the first listed.
NCT05041699 reports a single indexed study location in Oregon, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05041699 about?
NCT05041699 is a clinical study titled "PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel". A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
What is the current status of trial NCT05041699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-06-20. Estimated completion is 2024-10-07.
What conditions does trial NCT05041699 study?
This clinical trial studies the following conditions: Pharmacokinetics, Bleeding, Safety Issues.
What interventions are being tested in trial NCT05041699?
The interventions under investigation include: IPM Ring-105 (COMBINATION_PRODUCT), IPM Ring-106 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05041699?
This trial is sponsored by International Partnership for Microbicides, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05041699 being conducted?
This trial has 2 study locations across Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05041699's enrollment target sits among peer trials
40 9th of 37 higher than 26 of 37 other Pharmacokinetics trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pharmacokinetics 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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