Bacterial VaginosisPhase 4NCT02432404

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

A Phase 4 study testing NuvaRing in people with Bacterial Vaginosis, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Bacterial Vaginosis
What is being tested?: NuvaRing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteUnited States
Study dates: Mar 2016to Nov 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

≥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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UW Virology Research Clinic
Seattle, Washington, 98104

Other trials in United States

About this study

Conditions: Bacterial Vaginosis
Being tested: NuvaRing
Keywords: HSV-2, Contraceptive Vaginal Ring
Medical subject headings: Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuvaRingDrug

Study groups in NCT02432404
Study group	Role	What they receive
Cyclic NuvaRing CVR Use	Active comparator	CVR use for 3 weeks, remove for 1 week, then replace Receives: Drug: NuvaRing
Continuous NuvaRing CVR Use	Experimental	CVR use for 4 weeks, then replace Receives: Drug: NuvaRing

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Up to 8 months

Secondary outcomes (1)

Number of Visits With BV
Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.
Measured: Up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Nov 2021

First posted4 May 2015 (estimated)
Study startMar 2016
Primary completionNov 2021
Study completionNov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02432404
Sponsor's protocol ID: STUDY00003584
Other IDs: U19AI113173
Status last verified: Jan 2025
First submitted: 24 Apr 2015
Last updated: 5 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 15339769
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.
PubMed 18614873
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.
PubMed 22745608
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.
PubMed 21975269
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.
PubMed 24023807

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

All Bacterial Vaginosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity
ClinicalTrials.gov ID: NCT02432404
Acronym / sponsor ID: STUDY00003584
Conditions: Bacterial Vaginosis
Keywords: HSV-2, Contraceptive Vaginal Ring
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Mar 2016 (actual)
Primary completion: Nov 2021 (actual)
Study completion: Nov 2021 (actual)
First posted: 4 May 2015 (estimated)
Results: Posted 5 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cyclic NuvaRing CVR Use	Active comparator	Drug: NuvaRingCVR use for 3 weeks, remove for 1 week, then replace
Continuous NuvaRing CVR Use	Experimental	Drug: NuvaRingCVR use for 4 weeks, then replace

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

≥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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NuvaRing	Drug	Continuous NuvaRing CVR Use, Cyclic NuvaRing CVR Use

Primary outcome

Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
Time frame: Up to 8 months
Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)

1 secondary outcome

Number of Visits With BV
Time frame: Up to 8 months

Results and safety

Results posted to the registry on 5 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NuvaRing CVR Use	81	45

Primary outcome: Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests

Time frame: Up to 8 months. Mean (Standard Deviation). Unit: log10 copies/ml

Measure	NuvaRing CVR Use n = 57
G. vaginalis Baseline (M1-M2)	5.59 (2.27)
G. vaginalis Nuvaring (M2-M3)	5.22 (2.42)
G. vaginalis Nuvaring (M3-M6)	4.91 (2.13)
L. iners Baseline (M1-M2)	7.41 (2.80)
L. iners Nuvaring (M2-M3)	7.49 (2.90)
L. iners Nuvaring (M3-M6)	7.89 (2.32)
L. crispatus Baseline (M1-M2)	5.60 (3.42)
L. crispatus Nuvaring (M2-M3)	5.82 (3.42)

NuvaRing CVR Use: Mean Difference (Final Values): -0.37, p = 0.011, Random effects mixed model
NuvaRing CVR Use: Mean Difference (Final Values): -0.69, p = 0.008, Random effects mixed model
NuvaRing CVR Use: Mean Difference (Final Values): 0.08, p = 0.662, Random effects mixed model

Population analysed: Participants who initiated the ring and had at least one followup month in M3/4/5/6

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NuvaRing CVR Use	0 of 81 (0%)	8 of 45 (17.8%)	0 of 81

Limitations and caveats (from the sponsor): High rate of participant withdrawal from the study Single center experience

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15339769Veres 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.
Background: PubMed 18614873Atashili 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.
Background: PubMed 22745608Cohen 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.
Background: PubMed 21975269Heffron 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.
Background: PubMed 24023807Vodstrcil 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.

Related trials for Bacterial Vaginosis

Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Johnston, MD, MPH principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NuvaRing in people with Bacterial Vaginosis, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests (time frame: Up to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02432404, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.