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NCT04814927 · ClinicalTrials.gov registry record · Phase 4

Impact of Contraceptives on Cervico-Vaginal Mucosa

A Phase 4 study, sponsored by Eastern Virginia Medical School.

Completed
Registry status
Phase 4
Development phase
112
Enrollment target

NCT04814927: Completed Phase 4 study, sponsored by Eastern Virginia Medical School.

NCT04814927 is a Phase 4 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04814927, a Phase 4 study, has completed, sponsored by Eastern Virginia Medical School.

COMPLETED
Registry status
Phase 4
Development phase
112 participants
Enrollment target

Study Summary

UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.

Primary Outcome

Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function and reproductive health, including vaginal glycogen, pH, lactic acid, soluble markers and immune cells.

Interventions

  • DRUG Etonogestrel implant
  • DRUG Levonorgestrel IUS
  • DRUG Copper IUD
  • DRUG DMPA Sub-cutaneous

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2021-03-01
Est. Completion 2022-12-15
Phase Phase 4
Eastern Virginia Medical School

36 total trials

What the finished NCT04814927 record still lists

NCT04814927 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 4 interventions - of which Etonogestrel implant is the first listed.

NCT04814927 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04814927 about?

NCT04814927 is a clinical study titled "Impact of Contraceptives on Cervico-Vaginal Mucosa". UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assess...

What is the current status of trial NCT04814927?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2021-03-01. Estimated completion is 2022-12-15.

What interventions are being tested in trial NCT04814927?

The interventions under investigation include: Etonogestrel implant (DRUG), Levonorgestrel IUS (DRUG), Copper IUD (DRUG), DMPA Sub-cutaneous (DRUG).

Who is sponsoring clinical trial NCT04814927?

This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04814927's enrollment target sits among peer trials

112 724th of 2000 higher than 1,275 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT04814927, the US trial registry maintained by the National Library of Medicine. NCT04814927 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.