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The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis

NCT02905890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-03-12

No results posted yet for this study

Summary

The proposed study, Hormonal Contraception \& BV (HCBV), will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal inflammation.

Conditions

  • Bacterial Vaginosis
  • HIV

Interventions

DRUG

Norethisterone enantate

Noristerat® 200mg, solution for intramuscular injection given every 8 weeks

DEVICE

Condoms

Latex male condoms

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Suzanna C Francis, MSc MPH PHD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-12-20
Completion
2019-12-20

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT02905890 on ClinicalTrials.gov