The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis

• Status: Completed
• Trial end date: 2019-12-20
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Imperial College London; MRC/UVRI and LSHTM Uganda Research Unit; MRC/UVRI Uganda Research Unit on Aids; University of Liverpool
• Treatments: Norethindrone; Norethindrone Acetate; Norethindrone enanthate

Criteria

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