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NCT03660046 · ClinicalTrials.gov registry record

Contraceptive Hormones, Immunity, and Microbiome Evaluation

A clinical trial, sponsored by Emory University.

Completed
Registry status
155
Enrollment target

NCT03660046: Completed study, sponsored by Emory University.

NCT03660046 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 155 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03660046 has completed, sponsored by Emory University.

COMPLETED
Registry status
155 participants
Enrollment target

Study Summary

The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). The study seeks to test that HC induce immunologic changes capable of altering HIV susceptibilities, that these effects will vary by contraceptive type, and that they will be modified by the vaginal microenvironment.

Primary Outcome

Using Fortessa flow cytometer and Luminex, effector memory Cluster Differentiation 4 (CD4) + Thymocytes (T) cells will be analyzed for surface expression of HIV coreceptors cell surface receptor C-C chemokine receptor type 5 (CCR5) and reported as percent of total leukocytes and CD4+ T-cells. The cytometry will use the cervicovaginal fluid (CVF) collected by cervicovaginal lavage (CVL).This test will characterize the alterations in female genital and systemic immune profiles associated with thre

Interventions

  • DRUG Depot medroxyprogesterone acetate (DMPA)
  • DRUG Etonogestrel implant (Eng-Implant)
  • DRUG Levonorgestrel IUD (Lng-IUD)

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2018-12-07
Est. Completion 2023-09-07
Emory University

1,208 total trials

What the finished NCT03660046 record still lists

NCT03660046 is an observational study that tracks outcomes without assigning an intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 3 interventions - of which Depot medroxyprogesterone acetate (DMPA) is the first listed.

NCT03660046 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03660046 about?

NCT03660046 is a clinical study titled "Contraceptive Hormones, Immunity, and Microbiome Evaluation". The study is a prospective cohort study to explore the mechanisms underlying the HIV risk associated with pharmacologic doses of exogenous sex hormones via hormonal contraceptives specially progestin-containing hormonal contraception (HC). The study seeks to test that HC induce immunologic changes c...

What is the current status of trial NCT03660046?

This trial is currently completed. The enrollment target is 155 participants. The study started on 2018-12-07. Estimated completion is 2023-09-07.

What interventions are being tested in trial NCT03660046?

The interventions under investigation include: Depot medroxyprogesterone acetate (DMPA) (DRUG), Etonogestrel implant (Eng-Implant) (DRUG), Levonorgestrel IUD (Lng-IUD) (DRUG).

Who is sponsoring clinical trial NCT03660046?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03660046, the US trial registry maintained by the National Library of Medicine. NCT03660046 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.