Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

Bacterial Vaginosis Clinical Trial

Official title:

Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432404
• Other study ID #: STUDY00003584
• Secondary ID: U19AI113173
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: November 2021

Study information

• Verified date: November 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess potential benefits associated with both intermittent (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women either with BV or at high risk for BV. The investigators will also recruit women who are HSV2-infected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• =18-40 year old women

• BV+ by Amsel criteria and Nugent score OR history of BV in the prior 6 months

• Willing to use the NuvaRing as directed

• Not intending or wishing to become pregnant over the course of the study

• Capable of providing written informed consent

Exclusion Criteria:

• Current pregnancy

• Desire/intent to become pregnant over the course of the study

• Women who are less than 6 weeks postpartum

• Contraindications to hormonal contraceptive use per package insert, including history of deep vein thrombosis, smoking in women older than 35 years

• Current IUD

• Unable to comprehend consent material because of language barrier or psychological difficulty

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginosis, Bacterial

Intervention

Drug:
• NuvaRing

Locations

Country	Name	City	State
United States	UW Virology Research Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS. 2008 Jul 31;22(12):1493-501. doi: 10.1097/QAD.0b013e3283021a37. Review. — View Citation

Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA. Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. PLoS Med. 2012;9(6):e1001251. doi: 10.1371/journal.pmed.1001251. Epub 2012 Jun 26. — View Citation

Heffron R, Donnell D, Rees H, Celum C, Mugo N, Were E, de Bruyn G, Nakku-Joloba E, Ngure K, Kiarie J, Coombs RW, Baeten JM; Partners in Prevention HSV/HIV Transmission Study Team. Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study. Lancet Infect Dis. 2012 Jan;12(1):19-26. doi: 10.1016/S1473-3099(11)70247-X. Epub 2011 Oct 3. Erratum in: Lancet Infect Dis. 2012 Feb;12(2):98. — View Citation

Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. — View Citation

Vodstrcil LA, Hocking JS, Law M, Walker S, Tabrizi SN, Fairley CK, Bradshaw CS. Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis. PLoS One. 2013 Sep 4;8(9):e73055. doi: 10.1371/journal.pone.0073055. eCollection 2013. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of BV-associated bacteria by qPCR and high-throughput sequencing tests		Up to 8 months
Secondary	Quantity of vaginal defensins and cytokines		Up to 8 months
Secondary	Rates of incident BV		Up to 8 months
Secondary	Rates of HSV-2 viral shedding among HSV-2-infected women assessed by PCR		Up to 3 months