Trial Outcomes & Findings for Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women (NCT NCT01721798)
NCT ID: NCT01721798
Last Updated: 2024-02-05
Results Overview
Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
Enrollment to 24 months
Results posted on
2024-02-05
Participant Flow
Participant milestones
| Measure |
Non-ART/LNG-IUD
Not eligible to use antiretroviral therapy at enrollment (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
31
|
65
|
67
|
|
Overall Study
6 Mos
|
35
|
30
|
60
|
62
|
|
Overall Study
12 Mos
|
34
|
29
|
58
|
62
|
|
Overall Study
18 Mos
|
32
|
29
|
55
|
60
|
|
Overall Study
COMPLETED
|
32
|
29
|
44
|
48
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
21
|
19
|
Reasons for withdrawal
| Measure |
Non-ART/LNG-IUD
Not eligible to use antiretroviral therapy at enrollment (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
9
|
9
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
1
|
|
Overall Study
Not eligible for 24 month visit
|
1
|
0
|
8
|
7
|
Baseline Characteristics
Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women
Baseline characteristics by cohort
| Measure |
Non-ART/LNG-IUD
n=36 Participants
Not using ART at Enrollment (per national guidelines at study start, ART eligibility was initially limited to CD4\<350 cells/mm3. This criteria was changed in 2015 to a threshold of CD4\<500 cells/mm3 with an accompanying protocol amendment and then again in 2016 when ART initiation at diagnosis became standard of care, with a further protocol amendment. As such, there are relatively few participants in this arm.)/ LNG-IUD (the hormonal IUD used in this study is a T-shaped device containing 52mg levonorgestrel, releasing 20 mcg levonorgestrel daily.)
|
Non-ART/C-IUD
n=31 Participants
Not using ART at Enrollment: (per national guidelines at study start, ART eligibility was initially limited to CD4\<350 cells/mm3. This criteria was changed in 2015 to a threshold of CD4\<500 cells/mm3 with an accompanying protocol amendment and then again in 2016 when ART initiation at diagnosis became standard of care, with a further protocol amendment. As such, there are relatively few participants in this arm.) /C-IUD (The copper IUD used in this study is the copper T Cu380A, containing 380 mm2 of exposed copper wire.)
|
ART Use at Enrollment/LNG-IUD
n=65 Participants
Using ART at Enrollment (two new study arms were added in 2015 to include women using ART with clinical viral suppression (plasma viral load\<1000 copies/mL) and change the primary outcome measure to detectable genital HIV RNA)/LNG-IUD (the hormonal IUD used in this study is a T-shaped device containing 52mg levonorgestrel, releasing 20 mcg levonorgestrel daily.)
|
ART Use at Enrollment/C-IUD
n=67 Participants
Using ART at Enrollment (two new study arms were added in 2015 to include women using ART with clinical viral suppression (plasma viral load\<1000 copies/mL) and change the primary outcome measure to detectable genital HIV RNA)/C-IUD (The copper IUD used in this study is the copper T Cu380A, containing 380 mm2 of exposed copper wire.)
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
30.6 Years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
30.2 Years
STANDARD_DEVIATION 5.0 • n=7 Participants
|
31.8 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
31.4 Years
STANDARD_DEVIATION 4.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
South Africa
|
36 participants
n=5 Participants
|
31 participants
n=7 Participants
|
65 participants
n=5 Participants
|
67 participants
n=4 Participants
|
199 participants
n=21 Participants
|
|
Recent (<=16 weeks) exposure to injectable progestin contraception
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Enrollment to 24 monthsPopulation: As-treated contributing any person-time at follow-up; proportions with detectable genital tract HIV RNA compared in longitudinal analysis.
Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.
Outcome measures
| Measure |
Non-ART (Not Using Antiretroviral Therapy)/ Levonorgestrel Intrauterine Device (LNG-IUD)
n=36 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
n=31 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
n=65 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
n=67 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
Enrollment
|
18 Participants
|
23 Participants
|
10 Participants
|
7 Participants
|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
3 mos
|
19 Participants
|
18 Participants
|
8 Participants
|
11 Participants
|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
6 mos
|
20 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
12 mos
|
21 Participants
|
16 Participants
|
5 Participants
|
10 Participants
|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
18 mos
|
22 Participants
|
13 Participants
|
11 Participants
|
14 Participants
|
|
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
24 mos
|
14 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 24 monthsPopulation: Women recorded as using ART at a scheduled study visit with continued use of allocated intrauterine device.
The proportion of women using ART at enrollment with detectable plasma HIV RNA viral load. Viral load assays detected HIV RNA levels at 20-40 copies/mL as the lower limit of detection. The outcome measure coded values above that limit as detectable and those below as undetectable for women using ART and in mean viral load for women not using ART.
Outcome measures
| Measure |
Non-ART (Not Using Antiretroviral Therapy)/ Levonorgestrel Intrauterine Device (LNG-IUD)
n=65 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
n=67 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
Enrollment
|
14 Participants
|
12 Participants
|
—
|
—
|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
3 mos
|
11 Participants
|
20 Participants
|
—
|
—
|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
6 mos
|
18 Participants
|
19 Participants
|
—
|
—
|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
12 mos
|
18 Participants
|
22 Participants
|
—
|
—
|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
18 mos
|
15 Participants
|
20 Participants
|
—
|
—
|
|
Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)
24 mos
|
14 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Enrollment to 24 monthsPopulation: Participants continuing use of the allocated intrauterine device (IUD) and having hemoglobin measured at 6-month intervals.
Participant hemoglobin measured at baseline, 6, 12, 18, and 24 months with blood sample with mean hemoglobin calculated and trends over time assessed. Other safety measures were included with this secondary outcome, such as adverse events, summarized with descriptive statistics.
Outcome measures
| Measure |
Non-ART (Not Using Antiretroviral Therapy)/ Levonorgestrel Intrauterine Device (LNG-IUD)
n=36 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
n=31 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
n=65 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
n=67 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
Enrollment
|
12.4 grams/deciliter
Standard Deviation 1.3
|
12.8 grams/deciliter
Standard Deviation 1.0
|
12.4 grams/deciliter
Standard Deviation 1.1
|
12.2 grams/deciliter
Standard Deviation 1.3
|
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
6 months
|
12.6 grams/deciliter
Standard Deviation 1.3
|
12.3 grams/deciliter
Standard Deviation 1.2
|
12.5 grams/deciliter
Standard Deviation 1.4
|
11.8 grams/deciliter
Standard Deviation 1.6
|
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
12 months
|
12.5 grams/deciliter
Standard Deviation 1.1
|
12.3 grams/deciliter
Standard Deviation 0.89
|
12.6 grams/deciliter
Standard Deviation 0.86
|
11.8 grams/deciliter
Standard Deviation 1.4
|
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
18 months
|
12.4 grams/deciliter
Standard Deviation 1.0
|
12.4 grams/deciliter
Standard Deviation 0.85
|
12.6 grams/deciliter
Standard Deviation 1.4
|
11.7 grams/deciliter
Standard Deviation 1.3
|
|
Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety
24 months
|
12.6 grams/deciliter
Standard Deviation 1.0
|
12.6 grams/deciliter
Standard Deviation 1.7
|
12.6 grams/deciliter
Standard Deviation 0.91
|
11.6 grams/deciliter
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Enrollment to 24 monthsPopulation: Participants receiving the allocated IUD and contributing follow-up time at scheduled and unscheduled (e.g., request for IUD removal) visits. Analysis was proportion of women continuing their allocated IUD over time. The denominator at each scheduled visit changed based on number presenting or eligible (at 24 mos) for follow-up visits.
Measure of the number of women continuing to use the allocated intrauterine device (IUD) across all visits as a measure of acceptability. Proportion of women using the allocated IUD measured at each scheduled visit with time using the IUD adjusted for discontinuation at unscheduled visits. Continuation rate analyzed longitudinally with Kaplan-Meier survival analysis.
Outcome measures
| Measure |
Non-ART (Not Using Antiretroviral Therapy)/ Levonorgestrel Intrauterine Device (LNG-IUD)
n=36 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
n=31 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
n=65 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
n=67 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
3 mos
|
36 Participants
|
21 Participants
|
60 Participants
|
58 Participants
|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
6 mos
|
35 Participants
|
20 Participants
|
60 Participants
|
49 Participants
|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
12 mos
|
33 Participants
|
18 Participants
|
56 Participants
|
39 Participants
|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
18 mos
|
28 Participants
|
16 Participants
|
49 Participants
|
31 Participants
|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
Enrollment
|
36 Participants
|
31 Participants
|
65 Participants
|
67 Participants
|
|
Participants Continuing Use of the Allocated Intrauterine Device (IUD)
24 mos
|
28 Participants
|
13 Participants
|
38 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Women living with HIV who were not using ART receiving the allocated intrauterine device (IUD) had lower genital tract samples taken for genital tract viral load by three different methods: menstrual cup, endocervical swab, \& swab-enriched lavage, at enrollment, 3-, and 6-month visits. Sampling order varied by visit (e.g., enrollment: menstrual cup, endocervical swab, endocervical swab-enriched lavage). The number in each group was different at enrollment, 3 months and 6 months.
Proportion of specimens with quantifiable genital viral load compared by specific sampling method (menstrual cup, endocervical swab, and swab-enriched lavage) at enrollment, 3 months and 6 months among women not using antiretroviral therapy (ART). Allocated intrauterine device (IUD) was not considered in this analysis.
Outcome measures
| Measure |
Non-ART (Not Using Antiretroviral Therapy)/ Levonorgestrel Intrauterine Device (LNG-IUD)
n=51 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
Non-ART/C-IUD
n=51 Participants
Not eligible to use antiretroviral therapy (ART) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
ART Use at Enrollment/LNG-IUD
n=51 Participants
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the levonorgestrel 52 mg intrauterine device (LNG-IUD)
|
ART Use at Enrollment/C-IUD
Using antiretroviral therapy (ART) and virally suppressed (plasma viral load\<1000 copies/mL) at enrollment/ randomized to and received the copper T380-A intrauterine device (C-IUD) containing approximately 380 mm2 of exposed copper surface area
|
|---|---|---|---|---|
|
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
Enrollment
|
28 Participants
|
18 Participants
|
21 Participants
|
—
|
|
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
3 months
|
26 Participants
|
14 Participants
|
21 Participants
|
—
|
|
HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method
6 months
|
19 Participants
|
16 Participants
|
23 Participants
|
—
|
Adverse Events
Non-ART/LNG-IUD
Serious events: 12 serious events
Other events: 36 other events
Deaths: 0 deaths
Non-ART/C-IUD
Serious events: 12 serious events
Other events: 31 other events
Deaths: 0 deaths
ART Use at Enrollment/LNG-IUD
Serious events: 8 serious events
Other events: 63 other events
Deaths: 1 deaths
ART Use at Enrollment/C-IUD
Serious events: 7 serious events
Other events: 65 other events
Deaths: 1 deaths
All Women Using LNG-IUD
Serious events: 20 serious events
Other events: 99 other events
Deaths: 1 deaths
All Women Using C-IUD
Serious events: 19 serious events
Other events: 96 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Non-ART/LNG-IUD
n=36 participants at risk
Not using ART at Enrollment/LNG-IUD
|
Non-ART/C-IUD
n=31 participants at risk
Not using ART at Enrollment//C-IUD
|
ART Use at Enrollment/LNG-IUD
n=65 participants at risk
Using ART at Enrollment/LNG-IUD
|
ART Use at Enrollment/C-IUD
n=67 participants at risk
Using ART at Enrollment/C-IUD
|
All Women Using LNG-IUD
n=101 participants at risk
All women with equal to or more than one event using LNG-IUD
|
All Women Using C-IUD
n=98 participants at risk
All women with equal to or more than one event using C-IUD
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Right Tubal Ectopic Pregnancy
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Psychiatric disorders
Depression
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.7%
3/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.1%
3/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Immune system disorders
Low CD4 count
|
25.0%
9/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
16.1%
5/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
8.9%
9/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.1%
5/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Surgical and medical procedures
Gallstones
|
2.8%
1/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Pelvic Inflammatory Disease
|
2.8%
1/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.1%
2/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.0%
3/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with IUD in place
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Psychiatric disorders
Mood disorder
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Surgical and medical procedures
Hernia Surgery
|
2.8%
1/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Injury, poisoning and procedural complications
Death - possibly injury
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Hepatobiliary disorders
Liver failure/injury
|
2.8%
1/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Injury, poisoning and procedural complications
Car accident- Broken Leg - Hospitalization
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Injury, poisoning and procedural complications
Accident - Broken Leg - Hospitalization
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Abscess/Vagina Labia Majora
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Psychiatric disorders
Admission to psychiatric hospital
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Nervous system disorders
Stroke
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.99%
1/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical intraepithelial neoplasia
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
General disorders
Death - unknown reasons
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Psychiatric disorders
IUD expulsion
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
Other adverse events
| Measure |
Non-ART/LNG-IUD
n=36 participants at risk
Not using ART at Enrollment/LNG-IUD
|
Non-ART/C-IUD
n=31 participants at risk
Not using ART at Enrollment//C-IUD
|
ART Use at Enrollment/LNG-IUD
n=65 participants at risk
Using ART at Enrollment/LNG-IUD
|
ART Use at Enrollment/C-IUD
n=67 participants at risk
Using ART at Enrollment/C-IUD
|
All Women Using LNG-IUD
n=101 participants at risk
All women with equal to or more than one event using LNG-IUD
|
All Women Using C-IUD
n=98 participants at risk
All women with equal to or more than one event using C-IUD
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Amenorrhea
|
47.2%
17/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.7%
3/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
49.2%
32/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
11.9%
8/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
48.5%
49/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
11.2%
11/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Blood and lymphatic system disorders
Menorrhagia
|
5.6%
2/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
35.5%
11/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
25.4%
17/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.0%
5/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
28.6%
28/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Blood and lymphatic system disorders
Intermenstrual bleeding
|
27.8%
10/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
16.1%
5/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
20.0%
13/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
25.4%
17/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
22.8%
23/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
22.4%
22/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Blood and lymphatic system disorders
Irregular/heavy uterine bleeding
|
11.1%
4/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
19.4%
6/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.2%
4/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.4%
7/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.9%
8/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
13.3%
13/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Blood and lymphatic system disorders
Menstrual disorder
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.8%
7/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.5%
5/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.9%
7/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.1%
5/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Pelvic pain
|
47.2%
17/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
48.4%
15/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
18.5%
12/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
22.4%
15/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
28.7%
29/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
30.6%
30/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
8.3%
3/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
25.8%
8/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.4%
7/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.9%
6/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
15.3%
15/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Enlarged Abdomen
|
8.3%
3/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.5%
2/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.5%
5/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.9%
6/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.1%
7/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.0%
6/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.0%
3/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.1%
7/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Reproductive system and breast disorders
Lower back pain
|
11.1%
4/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.5%
2/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.0%
5/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
2.0%
2/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Infections and infestations
Leukorrhea
|
5.6%
2/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
12.9%
4/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.0%
6/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
5.0%
5/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.2%
10/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Infections and infestations
Cervicitis
|
5.6%
2/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.2%
1/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.6%
3/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
2.0%
2/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
General disorders
Weight gain
|
13.9%
5/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
16.1%
5/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.2%
6/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
11.9%
8/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.9%
11/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
13.3%
13/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
General disorders
Weight loss
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.1%
2/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
2.0%
2/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.0%
1/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
General disorders
Headache
|
19.4%
7/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
9.7%
3/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.1%
2/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.0%
4/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
8.9%
9/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.1%
7/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
2/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
25.8%
8/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.0%
2/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
3.0%
3/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
10.2%
10/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
General disorders
Nausea
|
5.6%
2/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
16.1%
5/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
7.7%
5/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
1.5%
1/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.9%
7/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
6.1%
6/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/36 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
12.9%
4/31 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/65 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/67 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
0.00%
0/101 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
4.1%
4/98 • Participant follow-up time was up to 24 months; we followed unresolved adverse events a further 3-6 months until a final disposition was recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place