Trial Outcomes & Findings for Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women (NCT NCT01539226)
NCT ID: NCT01539226
Last Updated: 2022-10-19
Results Overview
HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1959 participants
Primary outcome timeframe
24 months
Results posted on
2022-10-19
Participant Flow
Participants were screened between 27 March 2012 and 22 Oct 2014. The IPM 027 trial was originally designed with a sample size of approximately 1,650 participants, which was increased to approximately 1,950 participants according to the amended protocol (Protocol Version 1.0 Amendment 3.0, dated 12 September 2013). Participants were recruited and enrolled at 6 RCs in South Africa and 1 RC in Uganda. A total of 3,425 participants were screened, of whom 1,959 participants were enrolled.
Participants who provided written informed consent at Screening Visit 1 were invited to undergo screening assessments for the trial. Participant screening was conducted over two scheduled Screening Visits with a maximum window period of 28 days between the two visits.
Participant milestones
| Measure |
Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
Dapivirine Vaginal Ring
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
|---|---|---|
|
Overall Study
STARTED
|
652
|
1307
|
|
Overall Study
COMPLETED
|
435
|
902
|
|
Overall Study
NOT COMPLETED
|
217
|
405
|
Reasons for withdrawal
| Measure |
Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
Dapivirine Vaginal Ring
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
54
|
|
Overall Study
Lost to Follow-up
|
20
|
54
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Pregnancy
|
13
|
29
|
|
Overall Study
inappropriate enrollment
|
0
|
1
|
|
Overall Study
Multiple Reasons
|
3
|
1
|
|
Overall Study
not HIV seroconversion-related
|
93
|
176
|
|
Overall Study
HIV seroconversion-related
|
55
|
80
|
|
Overall Study
Non-compliance
|
6
|
8
|
Baseline Characteristics
Only this number of participants provided a response.
Baseline characteristics by cohort
| Measure |
Placebo Vaginal Ring
n=652 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
Dapivirine Vaginal Ring
n=1307 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Total
n=1959 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 5.92 • n=652 Participants
|
25.9 years
STANDARD_DEVIATION 5.85 • n=1307 Participants
|
26.0 years
STANDARD_DEVIATION 5.87 • n=1959 Participants
|
|
Sex: Female, Male
Female
|
652 Participants
n=652 Participants
|
1307 Participants
n=1307 Participants
|
1959 Participants
n=1959 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
Black or African American
|
642 Participants
n=652 Participants
|
1299 Participants
n=1307 Participants
|
1941 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=652 Participants
|
0 Participants
n=1307 Participants
|
0 Participants
n=1959 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=652 Participants
|
8 Participants
n=1307 Participants
|
18 Participants
n=1959 Participants
|
|
Region of Enrollment
South Africa
|
587 participants
n=652 Participants
|
1175 participants
n=1307 Participants
|
1762 participants
n=1959 Participants
|
|
Region of Enrollment
Uganda
|
65 participants
n=652 Participants
|
132 participants
n=1307 Participants
|
197 participants
n=1959 Participants
|
|
BMI
|
28.2 kg/(m^2)
STANDARD_DEVIATION 6.80 • n=652 Participants
|
28.1 kg/(m^2)
STANDARD_DEVIATION 7.12 • n=1307 Participants
|
28.1 kg/(m^2)
STANDARD_DEVIATION 7.01 • n=1959 Participants
|
|
Education level
secondary education
|
371 Participants
n=652 Participants
|
775 Participants
n=1307 Participants
|
1146 Participants
n=1959 Participants
|
|
Education level
primary education
|
228 Participants
n=652 Participants
|
384 Participants
n=1307 Participants
|
612 Participants
n=1959 Participants
|
|
Education level
tertiary education
|
29 Participants
n=652 Participants
|
90 Participants
n=1307 Participants
|
119 Participants
n=1959 Participants
|
|
Education level
unknown
|
24 Participants
n=652 Participants
|
58 Participants
n=1307 Participants
|
82 Participants
n=1959 Participants
|
|
Marital status
Never married
|
581 Participants
n=652 Participants
|
1166 Participants
n=1307 Participants
|
1747 Participants
n=1959 Participants
|
|
Marital status
Married
|
63 Participants
n=652 Participants
|
118 Participants
n=1307 Participants
|
181 Participants
n=1959 Participants
|
|
Marital status
Legally separated
|
7 Participants
n=652 Participants
|
13 Participants
n=1307 Participants
|
20 Participants
n=1959 Participants
|
|
Marital status
Widowed
|
0 Participants
n=652 Participants
|
8 Participants
n=1307 Participants
|
8 Participants
n=1959 Participants
|
|
Marital status
Divorced
|
1 Participants
n=652 Participants
|
2 Participants
n=1307 Participants
|
3 Participants
n=1959 Participants
|
|
Has children
|
601 Participants
n=652 Participants
|
1190 Participants
n=1307 Participants
|
1791 Participants
n=1959 Participants
|
|
Has main sex partner
|
640 Participants
n=652 Participants
|
1284 Participants
n=1307 Participants
|
1924 Participants
n=1959 Participants
|
|
Usual number of vaginal sex act each month
|
8.4 vaginal sex acts per month
STANDARD_DEVIATION 10.46 • n=625 Participants • Only this number of participants provided a response.
|
8.1 vaginal sex acts per month
STANDARD_DEVIATION 10.32 • n=1248 Participants • Only this number of participants provided a response.
|
8.2 vaginal sex acts per month
STANDARD_DEVIATION 10.37 • n=1873 Participants • Only this number of participants provided a response.
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: This population consisted of all participants included in the ITT population (all randomised), excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing.
HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1302 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=650 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.
|
82 Participants
|
61 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring.
Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. All AEs will be reported, regardless of grade or relatedness.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1306 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=652 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
All Adverse Events
|
1147 Participants
|
561 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: This population consisted of all participants included in the ITT population, excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing.
Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm in Appendix C of protocol.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1302 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=650 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
The Incidence Rate of HIV-2 Seroconversion.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring.
The percentage of participants testing positive for any STI (gonorrhoea, chlamydia, trichomonas, syphilis) will be assessed.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1271 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=624 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
The Incidence of Curable STIs
|
682 Participants
|
315 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring.
The percentage of participants with pregnancies in each treatment group. For each treatment group, the numerator will include the number of participants that had a positive urine pregnancy test during the trial period.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1306 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=652 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period;
|
43 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The objective measures (dapivirine residual levels in used rings and dapivirine plasma concentrations) used can only be determined for participants who used the active vaginal dapivirine ring.
Questionnaires and qualitative data regarding sexual behaviour and adherence to the use of a vaginal ring inserted once every 4 weeks over the trial period. Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use,
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1302 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 60
|
81.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 64
|
82.7 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 92
|
81.6 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 96
|
83.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 68
|
85.0 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 72
|
83.9 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 76
|
84.0 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 80
|
81.4 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 84
|
81.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 88
|
81.5 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 100
|
82.6 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 104
|
80.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 4
|
77.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 8
|
76.5 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 12
|
75.0 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 16
|
74.9 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 20
|
73.7 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 24
|
73.9 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 28
|
73.4 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 32
|
73.5 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 36
|
74.9 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 40
|
76.1 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 44
|
76.3 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 48
|
77.4 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 52
|
78.5 percentage of participants with data
|
—
|
|
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Week 56
|
78.9 percentage of participants with data
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: This population consisted of all participants included in the ITT population, excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing.
Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Number of participants with positive response. Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?'
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=1302 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=650 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;
Week 4
|
97.4 percentage of participants with data
|
98.7 percentage of participants with data
|
|
The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;
Week 24
|
98.7 percentage of participants with data
|
98.6 percentage of participants with data
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The virology population included all ITT participants with seroconversion, excluding those who never received investigational product, or were retrospectively found to be HIV-1 RNA positive at enrollment (m-ITT) or were HIV-1 infected after discontinuation of ring use. Seroconversions among participants who were continued on open-label DVR-004 were included in the DVR-004 group, independent of initial randomization.
The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters. The proportion of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.
Outcome measures
| Measure |
Dapivirine Vaginal Ring
n=87 Participants
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
Placebo Vaginal Ring
n=61 Participants
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
|---|---|---|
|
The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1.
|
84 Participants
|
58 Participants
|
Adverse Events
Placebo Vaginal Ring
Serious events: 9 serious events
Other events: 561 other events
Deaths: 3 deaths
Dapivirine Vaginal Ring
Serious events: 41 serious events
Other events: 1147 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo Vaginal Ring
n=652 participants at risk
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
Dapivirine Vaginal Ring
n=1306 participants at risk
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
|---|---|---|
|
Infections and infestations
Febrile Infection
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.23%
3/1306 • Number of events 3 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Malaria
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.23%
3/1306 • Number of events 3 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Acute Tonsillitis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Cystitis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.15%
2/1306 • Number of events 2 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.15%
2/1306 • Number of events 2 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.15%
2/1306 • Number of events 2 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.23%
3/1306 • Number of events 3 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Breast mass
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Nervous system disorders
Headache
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.23%
3/1306 • Number of events 3 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Vascular disorders
Circulatory collapse
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Eye disorders
Photophobia
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
General disorders
Pyrexia
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma stage unspecified
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Psychiatric disorders
Suicide attempt
|
0.15%
1/652 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.00%
0/1306 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/652 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
0.08%
1/1306 • Number of events 1 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
Other adverse events
| Measure |
Placebo Vaginal Ring
n=652 participants at risk
Vaginal Ring containing 0.0 mg Dapivirine
Placebo Vaginal Ring: Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
|
Dapivirine Vaginal Ring
n=1306 participants at risk
Vaginal Ring containing 25mg of Dapivirine
Dapivirine Vaginal Ring, 25 mg: Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
|---|---|---|
|
Infections and infestations
Gynaecological chlamydia infection
|
32.7%
213/652 • Number of events 328 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
32.7%
427/1306 • Number of events 669 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Genital infection female
|
19.3%
126/652 • Number of events 166 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
23.0%
300/1306 • Number of events 388 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
16.6%
108/652 • Number of events 146 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
19.3%
252/1306 • Number of events 333 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
115/652 • Number of events 247 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
17.7%
231/1306 • Number of events 536 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Trichomoniasis
|
15.8%
103/652 • Number of events 150 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
17.2%
225/1306 • Number of events 351 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Urinary tract infection
|
15.3%
100/652 • Number of events 151 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
14.2%
185/1306 • Number of events 261 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
12.9%
84/652 • Number of events 110 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
13.3%
174/1306 • Number of events 258 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Vulvovaginitis
|
11.0%
72/652 • Number of events 132 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
8.8%
115/1306 • Number of events 251 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Vaginitis bacterial
|
6.0%
39/652 • Number of events 50 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
7.6%
99/1306 • Number of events 129 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Viral rhinitis
|
5.4%
35/652 • Number of events 64 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
5.6%
73/1306 • Number of events 148 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
29/652 • Number of events 30 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
5.1%
66/1306 • Number of events 73 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Malaria
|
4.6%
30/652 • Number of events 43 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
4.7%
61/1306 • Number of events 93 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.7%
24/652 • Number of events 32 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
3.6%
47/1306 • Number of events 58 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
19/652 • Number of events 22 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
3.6%
47/1306 • Number of events 53 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Cervicitis
|
3.2%
21/652 • Number of events 26 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.2%
29/1306 • Number of events 31 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
2.6%
17/652 • Number of events 24 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.5%
33/1306 • Number of events 44 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Pelvic inflammatory disease
|
4.0%
26/652 • Number of events 28 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
1.6%
21/1306 • Number of events 25 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Infections and infestations
Pharyngitis
|
2.5%
16/652 • Number of events 19 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.4%
31/1306 • Number of events 34 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
29.6%
193/652 • Number of events 335 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
27.0%
353/1306 • Number of events 616 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.9%
71/652 • Number of events 112 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
10.3%
135/1306 • Number of events 231 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.8%
51/652 • Number of events 95 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
6.9%
90/1306 • Number of events 127 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
7.2%
47/652 • Number of events 56 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
6.7%
88/1306 • Number of events 98 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
6.4%
42/652 • Number of events 60 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
6.7%
87/1306 • Number of events 122 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.8%
25/652 • Number of events 26 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
5.4%
71/1306 • Number of events 78 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
3.2%
21/652 • Number of events 23 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
3.4%
45/1306 • Number of events 49 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Reproductive system and breast disorders
Vulval ulceration
|
3.7%
24/652 • Number of events 29 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.5%
33/1306 • Number of events 47 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
44/652 • Number of events 64 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
4.9%
64/1306 • Number of events 76 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Gastritis
|
4.4%
29/652 • Number of events 57 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
4.1%
53/1306 • Number of events 102 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
2.9%
19/652 • Number of events 19 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
3.1%
41/1306 • Number of events 46 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Constipation
|
3.4%
22/652 • Number of events 24 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.9%
38/1306 • Number of events 42 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
16/652 • Number of events 17 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.3%
30/1306 • Number of events 32 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
34/652 • Number of events 58 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
6.0%
79/1306 • Number of events 126 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
39/652 • Number of events 69 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
5.7%
74/1306 • Number of events 107 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
26/652 • Number of events 31 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
4.1%
53/1306 • Number of events 57 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Nervous system disorders
Headache
|
11.8%
77/652 • Number of events 95 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
8.6%
112/1306 • Number of events 139 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
2.6%
17/652 • Number of events 17 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.0%
26/1306 • Number of events 26 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.8%
12/652 • Number of events 14 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
2.3%
30/1306 • Number of events 35 • 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place