CompletedPhase 4

The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis

Uganda250 participantsStarted 2017-10-02

Plain-language 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.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * BV positive by Nugent score * HIV negative * Capable of providing written informed consent Exclusion Criteria: * Currently pregnant or using a reliable contraception (e.g. injectables, intrauterine devices, implant, oral contraceptive pills) * Desiring pregnancy in the next year * History of tubal ligation or hysterectomy * Contraindication to progestin-only contraceptives * Unable to comprehend consent material because of language barrier or psychological difficulty

What they're measuring

Time to diagnosis of recurrent BV

Timeframe: 6 months

Trial details

NCT IDNCT02905890

SponsorLondon School of Hygiene and Tropical Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-20

View on ClinicalTrials.gov More Bacterial Vaginosis trials