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NCT03917420 · ClinicalTrials.gov registry record · Phase 1
Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03917420: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03917420 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03917420, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Purpose: To Assess the impact of high and low in vivo estradiol exposure on PrEP (Pre-exposure prophylaxis) nucleotide concentrations in different cellular populations of the lower GI (gastrointestinal) tract and to quantify the relationship between estradiol, progesterone, and testosterone on PrEP nucleotide concentrations in rectal and peripheral blood mononuclear cells. As well as the relationship between estradiol, progesterone, and testosterone on PrEP concentrations in plasma. Participants: Healthy, cisgender female, volunteers, aged 18-49 inclusive on the date of screening with an intact gastrointestinal system and regular menstrual cycle. Procedures (methods): Participants will take a single daily dose of study drug for five days before each sampling visit. The visits will be scheduled during the early follicular phase of the menstrual cycle (approximately days 2-5 after the first day of menses, Visit 1) when estradiol is predicted to be the lowest and the late follicular phase (approximately days 12-15 after the first day of menses, Visit 2) when estradiol is predicted to be highest. Samples of blood, rectal cells, and rectal tissue will be collected at both Visits 1 and 2. All participants will complete a follow-up safety visit within 14 days of completing study sampling.
Primary Outcome
Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells.
Interventions
- DRUG Tenofovir 300Mg Oral Tablet
- DRUG Emtricitabine 200 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 1 |
What the finished NCT03917420 record still lists
NCT03917420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Tenofovir 300Mg Oral Tablet is the first listed.
NCT03917420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03917420 about?
NCT03917420 is a clinical study titled "Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract". Purpose: To Assess the impact of high and low in vivo estradiol exposure on PrEP (Pre-exposure prophylaxis) nucleotide concentrations in different cellular populations of the lower GI (gastrointestinal) tract and to quantify the relationship between estradiol, progesterone, and testosterone on PrEP ...
What is the current status of trial NCT03917420?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-03-26. Estimated completion is 2019-09-04.
What interventions are being tested in trial NCT03917420?
The interventions under investigation include: Tenofovir 300Mg Oral Tablet (DRUG), Emtricitabine 200 MG (DRUG).
Who is sponsoring clinical trial NCT03917420?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03917420's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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