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

NCT02432404 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: STUDY00003584U19AI113173
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis

Keywords

HSV-2; Contraceptive Vaginal Ring

Outcome Measures

Primary Outcomes (1)

• Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests

  Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)

  Up to 8 months

Secondary Outcomes (1)

• Number of Visits With BV

  Up to 8 months

Study Arms (2)

Cyclic NuvaRing CVR Use

ACTIVE COMPARATOR

CVR use for 3 weeks, remove for 1 week, then replace

Drug: NuvaRing

Continuous NuvaRing CVR Use

EXPERIMENTAL

CVR use for 4 weeks, then replace

Drug: NuvaRing

Interventions

NuvaRing DRUG

Continuous NuvaRing CVR Use; Cyclic NuvaRing CVR Use

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

UW Virology Research Clinic

Seattle, Washington, 98104, United States

Location

Related Publications (5)

• Veres S, Miller L, Burington B. A comparison between the vaginal ring and oral contraceptives. Obstet Gynecol. 2004 Sep;104(3):555-63. doi: 10.1097/01.AOG.0000136082.59644.13.

  PMID: 15339769 BACKGROUND

• 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.

  PMID: 18614873 BACKGROUND

• 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.

  PMID: 22745608 BACKGROUND

• 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.

  PMID: 21975269 BACKGROUND

• 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.

  PMID: 24023807 BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

NuvaRing

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

High rate of participant withdrawal from the study Single center experience

Results Point of Contact

• Title: Christine Johnston
• Organization: University of Washington

cjohnsto@uw.edu

206-520-4340

Study Officials

• Christine Johnston, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medicine/Division of Allergy and Infectious Diseases

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 4, 2015
• Study Start: March 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Locations

US (1)