Trial Outcomes & Findings for Effects of a Vaginal Contraceptive Ring on Vaginal Microbiota and Local Immunity (NCT NCT02432404)
NCT ID: NCT02432404
Last Updated: 2025-02-05
Results Overview
Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Up to 8 months
Results posted on
2025-02-05
Participant Flow
After 1 month baseline observation, participants initiated the CVR and were followed monthly for 4 months
Participant milestones
| Measure |
NuvaRing CVR Use
Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
NuvaRing
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
Initiated Nuvaring CVR
|
61
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
9 persons had missing age
Baseline characteristics by cohort
| Measure |
NuvaRing CVR Use
n=81 Participants
Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
NuvaRing
|
|---|---|
|
Age, Continuous
|
28 years
n=72 Participants • 9 persons had missing age
|
|
Sex: Female, Male
Female
|
81 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=81 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Up to 8 monthsPopulation: Participants who initiated the ring and had at least one followup month in M3/4/5/6
Change in Log10 quantity of bacteria detected (L. crisptatus, L. jensenii, L. iners, G. vaginalis, Megasphaera spp. BVAB2)
Outcome measures
| Measure |
NuvaRing CVR Use
n=2895 swabs
Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
|
|---|---|
|
Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
L. iners Nuvaring (M2-M3)
|
7.49 log10 copies/ml
Standard Deviation 2.90
|
|
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
|
|
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
|
|
Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
Megasphaera Baseline (M1-M2)
|
2.50 log10 copies/ml
Standard Deviation 1.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Quantity of BV-associated Bacteria by qPCR and High-throughput Sequencing Tests
L. iners Baseline (M1-M2)
|
7.41 log10 copies/ml
Standard Deviation 2.80
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Up to 8 monthsPopulation: Among participants who initiated the ring and had at least one followup month in M3/4/5/6
Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.
Outcome measures
| Measure |
NuvaRing CVR Use
n=320 Visits
Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
|
|---|---|
|
Number of Visits With BV
Visits with BV pre-CVR
|
15 Visits
|
|
Number of Visits With BV
Visits with BV at M3
|
6 Visits
|
|
Number of Visits With BV
Visits with BV at M4/5/6
|
4 Visits
|
Adverse Events
NuvaRing CVR Use
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NuvaRing CVR Use
n=45 participants at risk；n=81 participants at risk
Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.
|
|---|---|
|
Reproductive system and breast disorders
Vulvovaginal candidiasis
|
17.8%
8/45 • Number of events 8 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place