Trial Outcomes & Findings for Study of Dapivirine Vaginal Ring (VR) in Adolescents (NCT NCT02028338)
NCT ID: NCT02028338
Last Updated: 2022-10-24
Results Overview
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
6 months
Results posted on
2022-10-24
Participant Flow
As part of participant outreach and recruitment strategies, trial staff pre-screened potential trial participants at either on-site or off-site locations. During these interactions, trial staff explained the trial to potential participants, ascertained elements of presumptive eligibility.
Screening Visit were done up to 56 days prior to Enrollment Visit. Some cases, multiple visits were conducted to complete all screening procedures. Written informed participant assent and parental/guardian consent for screening were obtained. Participants who expressed an interest in involving her current sexual partner regarding trial participation was encouraged to bring her partner to the research center where a staff member explained the trial.
Participant milestones
| Measure |
Dapivirine Ring
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
23
|
|
Overall Study
COMPLETED
|
69
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Dapivirine Ring
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Unable to contact participant
|
1
|
0
|
Baseline Characteristics
Study of Dapivirine Vaginal Ring (VR) in Adolescents
Baseline characteristics by cohort
| Measure |
Dapivirine Ring
n=73 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=23 Participants
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.3 Years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
16.2 Years
STANDARD_DEVIATION 0.7 • n=7 Participants
|
16.3 Years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
73 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants randomized into the clinical trial were included in the primary analysis according to the principle of intent-to-treat (ITT).
Grade 2 AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009), Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to IP. Grade 3 or higher AEs as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, dated December 2004 (Clarification dated August 2009).
Outcome measures
| Measure |
Dapivirine Ring
n=73 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=23 Participants
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use
Grade 2 Adverse Events related to IP
|
8 Participants
|
2 Participants
|
|
The Safety of Dapivirine (25 mg) Administered Via a Silicone Vaginal Ring in HIV-uninfected Adolescent Females, When Inserted Once Every 4 Weeks During 24 Weeks of Study Product Use
Grade 3 or higher events
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The ITT population included all participants who were randomized to one of the two treatment groups, Dapivirine Vaginal Ring-004 or placebo ring. All participants who were included in a treatment group were analyzed as members of the group in which they were enrolled, regardless of adherence to the planned course of treatment.
Participant's self-report on multiple components of acceptability via attitudinal questions (discreetness, likes and dislikes concerning the ring, attitude toward product characteristics, comfort and ease of use, partner reactions, and effect on sex) in categorical scales
Outcome measures
| Measure |
Dapivirine Ring
n=70 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=22 Participants
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Discreetness · At least one negative report
|
39 Participants
|
12 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Discreetness · All responses positive
|
9 Participants
|
1 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Likes and dislikes concerning the ring · At least one negative report
|
18 Participants
|
7 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Likes and dislikes concerning the ring · All responses positive
|
37 Participants
|
12 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Attitude toward product characteristics · At least one negative report
|
14 Participants
|
4 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Attitude toward product characteristics · All responses positive
|
34 Participants
|
11 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Comfort and ease of use · At least one negative report
|
27 Participants
|
10 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Comfort and ease of use · All responses positive
|
36 Participants
|
12 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Partner reaction · At least one negative report
|
12 Participants
|
3 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Partner reaction · All responses positive
|
16 Participants
|
5 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Effect on sex · At least one negative report
|
9 Participants
|
6 Participants
|
|
The Acceptability of the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
Effect on sex · All responses positive
|
34 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The ITT population included all participants who were randomized to one of the two treatment groups, Dapivirine Vaginal Ring-004 or placebo ring. All participants who were included in a treatment group were analyzed as members of the group in which they were enrolled, regardless of adherence to the planned course of treatment.
Frequency of ring removals and expulsions based on the participant's self-report of ring use at monthly clinic visits according to the Ring Adherence CRF.
Outcome measures
| Measure |
Dapivirine Ring
n=73 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=23 Participants
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Adherence to the Study VR (Dapivirine or Placebo) in HIV Uninfected Adolescent Females, When Inserted Once Every 4 Weeks for a 24 Week Period
|
29 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The PK analysis population included all participants who were randomized to the Dapivirine Vaginal Ring-004 treatment group and had detectable dapivirine plasma or vaginal fluid concentrations at any time during follow-up.
Dapivirine plasma concentrations measured at weeks 2, 4, 12 and 24.
Outcome measures
| Measure |
Dapivirine Ring
n=73 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
The Systemic Dapivirine Exposure
Week 2
|
310.5 picograms/millilitre
Standard Deviation 102.0
|
—
|
|
The Systemic Dapivirine Exposure
Week 4
|
255.5 picograms/millilitre
Standard Deviation 91.1
|
—
|
|
The Systemic Dapivirine Exposure
Week 12
|
250.9 picograms/millilitre
Standard Deviation 96.6
|
—
|
|
The Systemic Dapivirine Exposure
Week 24
|
243.1 picograms/millilitre
Standard Deviation 116.3
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The PK analysis population included all participants who were randomized to the Dapivirine Vaginal Ring-004 treatment group and had detectable dapivirine plasma or vaginal fluid concentrations at any time during follow-up.
Vaginal fluid dapivirine concentrations.
Outcome measures
| Measure |
Dapivirine Ring
n=73 Participants
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Local Dapivirine Exposure
Week 2
|
27.8 nanogram/milligram
Standard Deviation 22.7
|
—
|
|
Local Dapivirine Exposure
Week 4
|
45.0 nanogram/milligram
Standard Deviation 40.9
|
—
|
|
Local Dapivirine Exposure
Week 12
|
49.2 nanogram/milligram
Standard Deviation 53.6
|
—
|
|
Local Dapivirine Exposure
Week 24
|
51.9 nanogram/milligram
Standard Deviation 58.2
|
—
|
Adverse Events
Dapivirine Ring
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo Ring
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapivirine Ring
n=73 participants at risk
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=23 participants at risk
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Renal and urinary disorders
Pelvic Inflammatory Disease
|
1.4%
1/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Surgical and medical procedures
Abdominal Incarcerated Hernia
|
1.4%
1/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
Other adverse events
| Measure |
Dapivirine Ring
n=73 participants at risk
dapivirine vaginal ring (25 mg)
dapivirine ring: intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
|
Placebo Ring
n=23 participants at risk
silicone vaginal ring
placebo ring: intravaginal ring silicone elastomer intravaginal ring containing no drug product
|
|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.8%
5/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Gastrointestinal disorders
Gastritis
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
4/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
General disorders
Pyrexia
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Bacterial vaginosis
|
12.3%
9/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Cystitis
|
0.00%
0/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Gastroenteritis
|
5.5%
4/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Genitourinary chlamydia infection
|
11.0%
8/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
5/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
13.0%
3/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Pelvic Inflammatory disease
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Sinusitis
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
4/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Urinary tract infection
|
12.3%
9/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
13.0%
3/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Viral infection
|
4.1%
3/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Viral Upper respiratory tract infection
|
4.1%
3/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
9.6%
7/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
13.0%
3/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Infections and infestations
Vulvovaginal Trichomonal
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
5/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.1%
3/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Nervous system disorders
Headache
|
8.2%
6/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Product Issues
Product Issue
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Renal and urinary disorders
Dysuria
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Renal and urinary disorders
Pollakiuria
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Breast tenderness
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.1%
3/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Menorrhagia
|
6.8%
5/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
8.7%
2/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
20.5%
15/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
26.1%
6/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
9.6%
7/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Uterine spasm
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
4.3%
1/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
15.1%
11/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
34.8%
8/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Reproductive system and breast disorders
Vaginal Odour
|
5.5%
4/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.7%
2/73 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
0.00%
0/23 • 25 weeks
Prior and concomitant medications were recorded at the Screening Visit and reviewed/updated at subsequent visits, and adverse events (AEs) were recorded after enrollment and recorded/updated at subsequent visits. Used rings were collected at the 4 Week, 8 Week, 12 Week, 16 Week, 20 Week, and 24 Week Visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER