Effects of a Vaginal Contraceptive Ring on Vaginal Microb... | NCT02432404

ID	Type	Description	Link
U19AI113173	U.S. NIH Grant/Contract		View source

Effects of a Vaginal Contraceptive Ring on Vaginal Microb... | NCT02432404 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NuvaRing	Drug		Continuous NuvaRing CVR Use Cyclic NuvaRing CVR Use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Visits With BV	Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.	Up to 8 months

Contacts/Locations Module

Name	Affiliation	Role
Christine Johnston, MD, MPH	University of Washington	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UW Virology Research Clinic		Seattle	Washington	98104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15339769	Background	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.
18614873	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.

ID	Title	Description
FG000	NuvaRing CVR Use	Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously. NuvaRing

Baseline Characteristics Module

ID	Title	Description
BG000	NuvaRing CVR Use	Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously. NuvaRing

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous		9 persons had missing age

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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)

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

Posted

Mean

Standard Deviation

log10 copies/ml

Up to 8 months

swabs

ID	Title	Description
OG000	NuvaRing CVR Use	Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.

Units	Counts
Participants

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NuvaRing CVR Use	Participants could choose to use NuvaringCVR for 3 weeks, remove for 1 week, then replace, or to use continuously.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Vulvovaginal candidiasis	Reproductive system and breast disorders		Systematic Assessment	Number of participants with vulvovaginal candidiasis at Final study visit

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Christine Johnston	University of Washington	206-520-4340		cjohnsto@uw.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 27, 2018	Apr 5, 2023	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D016585	Vaginosis, Bacterial

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

ID	Term
C516519	NuvaRing

Race (NIH/OMB)

Self-reported.

In this analysis, participants selected "other" as a category. This will be indicated in the more than one race" count, since "other" is not available.

Count of Participants

Participants

Title

Denominators

Categories

G. vaginalis Baseline (M1-M2)

Title	Measurements
	OG0005.59± 2.27

G. vaginalis Nuvaring (M2-M3)

Title	Measurements
	OG0005.22± 2.42

G. vaginalis Nuvaring (M3-M6)

Title	Measurements
	OG0004.91± 2.13

L. iners Baseline (M1-M2)

Title	Measurements
	OG0007.41± 2.80

L. iners Nuvaring (M2-M3)

Title	Measurements
	OG0007.49± 2.90

L. iners Nuvaring (M3-M6)

Title	Measurements
	OG0007.89± 2.32

L. crispatus Baseline (M1-M2)

Title	Measurements
	OG0005.60± 3.42

L. crispatus Nuvaring (M2-M3)

Title	Measurements
	OG0005.82± 3.42

L. crispatus Nuvaring (M3-M6)

Title	Measurements
	OG0005.94± 3.05

L. jensenii Baseline (M1-M2)

Title	Measurements
	OG0004.85± 2.74

L. jensenii Nuvaring (M2-M3)

Title	Measurements
	OG0004.97± 2.76

L. jensenii Nuvaring (M3-M6)

Title	Measurements
	OG0005.23± 2.27

Megasphaera Baseline (M1-M2)

Title	Measurements
	OG0002.50± 1.70

Megasphaera Nuvaring (M2-M3)

Title	Measurements
	OG0002.60± 1.83

Megasphaera Nuvaring (M3-M6)

Title	Measurements
	OG0002.20± 0.87

BVAB2 Baseline (M1-M2)

Title	Measurements
	OG0002.22± 1.27

BVAB2 Nuvaring (M2-M3)

Title	Measurements
	OG0002.29± 1.17

BVAB2 Nuvaring (M3-M6)

Title	Measurements
	OG0002.12± 0.56

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Non-Inferiority Type
OG000	Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.011	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	-0.37	2-Sided	Other
OG000	Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.008	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	-0.69	2-Sided	Other
OG000	Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.662	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.08	2-Sided	Other
OG000	Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.41	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.48	2-Sided	Other
OG000	Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.164	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.23	2-Sided	Other
OG000	Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model		0.183	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.35	2-Sided	Other
OG000	Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.506	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.12	2-Sided	Other
OG000	Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.119	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.38	2-Sided	Other
OG000	Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.510	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.10	2-Sided	Other
OG000	Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.168	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	-0.30	2-Sided	Other
OG000	Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.454	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	0.07	2-Sided	Other
OG000	Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)	Random effects mixed model	Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.	0.471	p<0.05 is considered statistically significant.	Mean Difference (Final Values)	-0.10	2-Sided	Other

Secondary

Number of Visits With BV

Number of visits with BV prior to use of NuvaRing CVR compared to during NuvaRing CVR use.

Among participants who initiated the ring and had at least one followup month in M3/4/5/6

Posted

Count of Units

Visits

Up to 8 months

Visits

ID	Title	Description
OG000	NuvaRing CVR Use	Participants could choose to use CVR for 3 weeks, remove for 1 week, then replace, or to use continuously. NuvaRing

Units	Counts
Participants	OG00057
Visits	OG000320

Title

Denominators