Trial Outcomes & Findings for Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women (NCT NCT02431273)
NCT ID: NCT02431273
Last Updated: 2019-07-02
Results Overview
Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-Threatening).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Days 0-21 following insertion of each IVR.
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
TDF (Single IVR), TDF-FTC (Dual IVR), TDF-FTC-MVC (Triple IVR)
All subjects will be asked to wear TDF (Single) IVRs for 7 days.
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days.
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days.
|
|---|---|
|
TDF (Single IVR)
STARTED
|
6
|
|
TDF (Single IVR)
COMPLETED
|
6
|
|
TDF (Single IVR)
NOT COMPLETED
|
0
|
|
TDF-FTC (Dual IVR)
STARTED
|
6
|
|
TDF-FTC (Dual IVR)
COMPLETED
|
6
|
|
TDF-FTC (Dual IVR)
NOT COMPLETED
|
0
|
|
TDF-FTC-MVC (Triple IVR)
STARTED
|
6
|
|
TDF-FTC-MVC (Triple IVR)
COMPLETED
|
6
|
|
TDF-FTC-MVC (Triple IVR)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
6 subjects were screened, entered, and completed Period 1: TDF-IVR (Single IVR) and Period 2: TDF-FTC (Dual IVR). 2 of the 6 original subjects, plus 4 new subjects entered Period 3: TDF-FTC-MVC (Triple IVR). Total of 6 subjects were analyzed for each Period.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
|
|---|---|
|
Age, Continuous
Period 1 and Period 2
|
26 years
n=6 Participants • 6 subjects were screened, entered, and completed Period 1: TDF-IVR (Single IVR) and Period 2: TDF-FTC (Dual IVR). 2 of the 6 original subjects, plus 4 new subjects entered Period 3: TDF-FTC-MVC (Triple IVR). Total of 6 subjects were analyzed for each Period.
|
|
Age, Continuous
Period 3
|
24.5 years
n=6 Participants • 6 subjects were screened, entered, and completed Period 1: TDF-IVR (Single IVR) and Period 2: TDF-FTC (Dual IVR). 2 of the 6 original subjects, plus 4 new subjects entered Period 3: TDF-FTC-MVC (Triple IVR). Total of 6 subjects were analyzed for each Period.
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Days 0-21 following insertion of each IVR.Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-Threatening).
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Pelvic Pain: Grade 1
|
4 participants
|
1 participants
|
4 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Pelvic Pain: Grade 2
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Vaginal Discharge: Grade 1
|
3 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Metrorrhagia: Grade 1
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Vulvovaginal Itching: Grade 1
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Cervicovaginal Erythema: Grade 1
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Diarrhea: Grade 1
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Malaise: Grade 1
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Odor: Grade 1
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Nausea: Grade 1
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Candida (monilial vulvovaginitis): Grade 2
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).Drug concentrations \[tenofovir (TFV), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)\] in cervicovaginal fluids (CVF) for each IVR combination.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
tenofovir disoproxil fumarate
|
58.1 ng/mg
Interval 43.9 to 97.4
|
43.1 ng/mg
Interval 31.0 to 65.0
|
96.9 ng/mg
Interval 14.5 to 137.1
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
tenofovir
|
13.9 ng/mg
Interval 6.2 to 19.3
|
15.9 ng/mg
Interval 7.1 to 20.0
|
28.0 ng/mg
Interval 24.3 to 31.9
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
Total tenofovir
|
36.2 ng/mg
Interval 31.3 to 60.6
|
34.4 ng/mg
Interval 26.9 to 48.7
|
70.0 ng/mg
Interval 59.2 to 80.6
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
emtricitabine
|
NA ng/mg
The IVR did not contain emtricitabine
|
896 ng/mg
Interval 367.0 to 1349.0
|
838.5 ng/mg
Interval 641.8 to 1171.2
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
maraviroc
|
NA ng/mg
The IVR did not contain maraviroc
|
NA ng/mg
The IVR did not contain maraviroc
|
429.8 ng/mg
Interval 253.2 to 626.2
|
PRIMARY outcome
Timeframe: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).Drug concentrations \[tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)\] in cervicovaginal lavage (CVL) were evaluated for each IVR combination.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)
tenofovir disoproxil fumarate
|
1,930 ng/mL
|
1,720 ng/mL
|
3,630 ng/mL
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)
tenofovir
|
611 ng/mL
Interval 242.0 to
|
927 ng/mL
Interval 315.0 to
|
2,670 ng/mL
|
PRIMARY outcome
Timeframe: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).Drug concentrations \[tenofovir disoproxil fumarate (TDF), tenofovir (TFV), tenofovir diphosphate (TFV-DP), emtricitabine (FTC) and maraviroc (MVC)\] in vaginal tissue (VT) were evaluated for each IVR combination.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
tenofovir
|
8.4 ng/mg
Interval 4.7 to 11.2
|
5.1 ng/mg
Interval 0.8 to 10.1
|
5.1 ng/mg
Interval 3.3 to 9.7
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
tenofovir diphosphate
|
303 ng/mg
Interval 277.0 to 938.0
|
289 ng/mg
Interval 110.0 to 603.0
|
301.9 ng/mg
Interval 177.1 to 823.8
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
emtricitabine
|
NA ng/mg
The IVR did not contain emtricitabine
|
23,950 ng/mg
|
104 ng/mg
Interval 63.7 to 301.7
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
maraviroc
|
NA ng/mg
The IVR did not contain maraviroc
|
NA ng/mg
The IVR did not contain maraviroc
|
141.8 ng/mg
Interval 82.5 to 212.0
|
PRIMARY outcome
Timeframe: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).Drug concentrations \[tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)\] in plasma were evaluated for each IVR combination.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma
tenofovir: Plasma
|
NA ng/mL
Data is below the lower limit of quantification
|
NA ng/mL
Data is below the lower limit of quantification
|
NA ng/mL
Data is below the lower limit of quantification
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma
emtricitabine: Plasma
|
NA ng/mL
The IVR did not contain emtricitabine
|
0.95 ng/mL
Interval 0.91 to 1.14
|
1.02 ng/mL
Interval 0.56 to 1.22
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma
maraviroc: Plasma
|
NA ng/mL
The IVR did not contain maraviroc
|
NA ng/mL
The IVR did not contain maraviroc
|
0.08 ng/mL
Interval 0.05 to 0.14
|
PRIMARY outcome
Timeframe: Time points at which outcome measure was assessed are Day 7 (day of IVR removal) and daily up to 14 days.Drug concentrations \[tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)\] in terminal half-life were evaluated for each IVR combination.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
n=6 Participants
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
tenofovir disoproxil fumarate: Terminal Half-life
|
11.8 Hour
Interval 10.6 to 14.4
|
14.2 Hour
Interval 11.7 to 15.4
|
18.3 Hour
Interval 11.8 to 24.2
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
tenofovir: Terminal Half-life
|
39.5 Hour
Interval 30.0 to 58.1
|
31.4 Hour
Interval 25.9 to 36.2
|
24.8 Hour
Interval 24.4 to 31.9
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
emtricitabine: Terminal Half-life
|
NA Hour
The IVR did not contain emtricitabine
|
19.1 Hour
Interval 13.5 to 20.1
|
17.0 Hour
Interval 15.5 to 17.8
|
|
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
maraviroc: Terminal Half-life
|
NA Hour
The IVR did not contain maraviroc
|
NA Hour
The IVR did not contain maraviroc
|
16.0 Hour
Interval 15.8 to 18.3
|
SECONDARY outcome
Timeframe: Days 0-21 following insertion of each IVR.Population: Data was not collected for the third study period.
Acceptability of the IVRs was assessed through reported willingness to use the IVR for 28 days in a real-world setting on a likert scale, 1 being "not at all confident" to 5 being "completely confident" for Periods 1 and 2.
Outcome measures
| Measure |
Period 1: TDF (Single IVR)
n=6 Participants
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
Period 2: TDF-FTC (Dual IVR)
n=6 Participants
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
Period 3: TDF-FTC-MVC (Triple IVR)
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Acceptability of the IVRs
|
3.5 units on a scale
Interval 1.0 to 5.0
|
4 units on a scale
Interval 1.0 to 5.0
|
—
|
Adverse Events
TDF (Single IVR)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TDF-FTC (Dual IVR)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
TDF-FTC-MVC (Triple IVR)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TDF (Single IVR)
n=6 participants at risk
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF IVR
|
TDF-FTC (Dual IVR)
n=6 participants at risk
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC IVR
|
TDF-FTC-MVC (Triple IVR)
n=6 participants at risk
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
TDF-FTC-MVC IVR
|
|---|---|---|---|
|
Reproductive system and breast disorders
Pelvic Pain
|
50.0%
3/6 • Number of events 5 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
33.3%
2/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
66.7%
4/6 • Number of events 5 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
33.3%
2/6 • Number of events 2 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Reproductive system and breast disorders
Vulvovaginal Itching
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Reproductive system and breast disorders
Cervicovaginal Erythema
|
50.0%
3/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 3 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Skin and subcutaneous tissue disorders
Odor
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
General disorders
Nausea
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
|
Infections and infestations
Candida (monilial vulvovaginitis)
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
0.00%
0/6 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place