Bacterial Vaginosis
Conditions
Keywords
HSV-2, Contraceptive Vaginal Ring
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.
Interventions
DRUGNuvaRing
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | Up to 8 months | Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Visits With BV | Up to 8 months | Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use. |
Countries
United States
Participant flow
Pre-assignment details
After 1 month baseline observation, participants initiated the CVR and were followed monthly for 4 months
Participants by arm
| Arm | Count |
|---|---|
| NuvaRing CVR Use Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
NuvaRing | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | NuvaRing CVR Use |
|---|---|
| Age, Continuous | 28 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 81 |
| other Total, other adverse events | 8 / 45 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
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)
Time frame: Up to 8 months
Population: Participants who initiated the ring and had at least one followup month in M3/4/5/6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | G. vaginalis Baseline (M1-M2) | 5.59 log10 copies/ml | Standard Deviation 2.27 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | G. vaginalis Nuvaring (M2-M3) | 5.22 log10 copies/ml | Standard Deviation 2.42 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | G. vaginalis Nuvaring (M3-M6) | 4.91 log10 copies/ml | Standard Deviation 2.13 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. iners Baseline (M1-M2) | 7.41 log10 copies/ml | Standard Deviation 2.8 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. iners Nuvaring (M2-M3) | 7.49 log10 copies/ml | Standard Deviation 2.9 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. iners Nuvaring (M3-M6) | 7.89 log10 copies/ml | Standard Deviation 2.32 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. crispatus Baseline (M1-M2) | 5.60 log10 copies/ml | Standard Deviation 3.42 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. crispatus Nuvaring (M2-M3) | 5.82 log10 copies/ml | Standard Deviation 3.42 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. crispatus Nuvaring (M3-M6) | 5.94 log10 copies/ml | Standard Deviation 3.05 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. jensenii Baseline (M1-M2) | 4.85 log10 copies/ml | Standard Deviation 2.74 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. jensenii Nuvaring (M2-M3) | 4.97 log10 copies/ml | Standard Deviation 2.76 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | L. jensenii Nuvaring (M3-M6) | 5.23 log10 copies/ml | Standard Deviation 2.27 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | Megasphaera Baseline (M1-M2) | 2.50 log10 copies/ml | Standard Deviation 1.7 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | Megasphaera Nuvaring (M2-M3) | 2.60 log10 copies/ml | Standard Deviation 1.83 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | Megasphaera Nuvaring (M3-M6) | 2.20 log10 copies/ml | Standard Deviation 0.87 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | BVAB2 Baseline (M1-M2) | 2.22 log10 copies/ml | Standard Deviation 1.27 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | BVAB2 Nuvaring (M2-M3) | 2.29 log10 copies/ml | Standard Deviation 1.17 |
| NuvaRing CVR Use | Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests | BVAB2 Nuvaring (M3-M6) | 2.12 log10 copies/ml | Standard Deviation 0.56 |
Comparison: Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)p-value: 0.011Random effects mixed model
Comparison: Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)p-value: 0.008Random effects mixed model
Comparison: Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)p-value: 0.662Random effects mixed model
Comparison: Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)p-value: 0.41Random effects mixed model
Comparison: Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)p-value: 0.164Random effects mixed model
Comparison: Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)p-value: 0.183Random effects mixed model
Comparison: Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)p-value: 0.506Random effects mixed model
Comparison: Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)p-value: 0.119Random effects mixed model
Comparison: Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)p-value: 0.51Random effects mixed model
Comparison: Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)p-value: 0.168Random effects mixed model
Comparison: Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)p-value: 0.454Random effects mixed model
Comparison: Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)p-value: 0.471Random effects mixed model
Secondary
Number of Visits With BV
Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.
Time frame: Up to 8 months
Population: Among participants who initiated the ring and had at least one followup month in M3/4/5/6
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NuvaRing CVR Use | Number of Visits With BV | Visits with BV pre-CVR | 15 Visits |
| NuvaRing CVR Use | Number of Visits With BV | Visits with BV at M3 | 6 Visits |
| NuvaRing CVR Use | Number of Visits With BV | Visits with BV at M4/5/6 | 4 Visits |