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Contraceptive Hormones, Immunity, and Microbiome Evaluation

NCT03660046 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2024-10-29

No results posted yet for this 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.

Conditions

  • Hormonal Contraception

Interventions

DRUG

Depot medroxyprogesterone acetate (DMPA)

Depot medroxyprogesterone acetate (DMPA) will be dispensed from the Grady Pharmacy Service and will be administered every 12 weeks at the standard dose of 150 mg Intramuscular injection, beginning from week 3 of study enrollment and repeated every 13 weeks

DRUG

Etonogestrel implant (Eng-Implant)

A standard Nexplanon rod Implant that is a subdermal implant in the arm. This will be placed at study week 3 by Dr. Haddad or a trained clinician. It contains Etonogestrel 68mg.

DRUG

Levonorgestrel IUD (Lng-IUD)

The Levonorgestrel Intrauterine Device (Lng-IUD) (Mirena or copper) will be placed at study week 3 by Dr. Haddad or a trained clinician.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Alicia Smith, PhD · Emory University

Eligibility

Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2023-09-07
Completion
2023-09-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03660046 on ClinicalTrials.gov