Trial Outcomes & Findings for Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard (NCT NCT03124160)
NCT ID: NCT03124160
Last Updated: 2024-09-25
Results Overview
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1105 participants
Primary outcome timeframe
3 years
Results posted on
2024-09-25
Participant Flow
Participant milestones
| Measure |
Mona Lisa® NT Cu380 Mini
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Mona Lisa® NT Cu380 Mini: Mona Lisa® NT Cu380 Mini
|
ParaGard® TCu380A
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Overall Study
STARTED
|
887
|
218
|
|
Overall Study
COMPLETED
|
426
|
91
|
|
Overall Study
NOT COMPLETED
|
461
|
127
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
Baseline characteristics by cohort
| Measure |
Mona Lisa® NT Cu380 Mini
n=887 Participants
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Mona Lisa® NT Cu380 Mini: Mona Lisa® NT Cu380 Mini
|
ParaGard® TCu380A
n=218 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
Total
n=1105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.3 years
STANDARD_DEVIATION 5.23 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 4.96 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 5.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
887 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
1105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
117 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
765 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
952 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Number of Participants
|
887 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
1105 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: includes only participants with an evaluable cycle for estimating efficacy
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=804 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
|
1.86 Pearl Index = Num preg per 100 person yr
Interval 1.2 to 2.74
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Participants with successful IUD insertion
IUD continuation at 36-months by product
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
IUD Continuation
|
426 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Immediate after IUD insertion attemptPopulation: Treated population: uterus was successfully sounded and IUD insertion attempt was made
Failed IUD insertion as measured by inability to place the IUD correctly
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=876 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=214 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Failed IUD Insertion
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: User population
Uterine perforation as measured by ultrasound
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Uterine Perforation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: user population
When the IUD is expelled from the uterus, either completely or partially.
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
IUD Expulsion (Complete and Partial)
|
66 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: User population with evaluable cycles
Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=9292 Number of 28-day cycles
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=2185 Number of 28-day cycles
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Vaginal Bleeding Patterns
|
54.4 percent
Interval 53.43 to 55.46
|
55.7 percent
Interval 53.54 to 57.75
|
SECONDARY outcome
Timeframe: 1 yearPercent of cycles with any pelvic pain will be calculated using all available cycles
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=9292 Number of 28-day cycles
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=2185 Number of 28-day cycles
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Pelvic Pain as Measured in the Subject Diary
|
72.3 percent
Interval 71.3 to 73.2
|
72.3 percent
Interval 70.4 to 74.1
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: User population
Number of participants who experienced any dysmenorrhea during the trial
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Dysmenorrhea
|
396 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: Pain level 10 minutes after IUD insertionPopulation: User population
Pain level on scale of 0=no pain to 10=worst imaginable pain as displayed on a paper form for study subject to indicate their level of pain
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Pain With and Shortly After Insertion as Recorded by Study Subjects
|
1.8 units on a scale
Standard Deviation 1.92
|
2.1 units on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: Right after IUD insertionInvestigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=875 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=213 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Ease of IUD Insertion as Recorded by the Investigator
Somewhat easy
|
132 Participants
|
43 Participants
|
|
Ease of IUD Insertion as Recorded by the Investigator
Easy
|
694 Participants
|
161 Participants
|
|
Ease of IUD Insertion as Recorded by the Investigator
Somewhat hard
|
41 Participants
|
6 Participants
|
|
Ease of IUD Insertion as Recorded by the Investigator
Hard
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: User population
Overall product satisfaction level at exit visit (highly satisfied, satisfied, dissatisfied, highly dissatisfied)
Outcome measures
| Measure |
Mona Lisa NT Cu380 Mini Participants <36 Years of Age
n=761 Participants
This is the FDA definition and uses evaluable cycles in the denominator and failures in the numerator, summarized in failures per 100 person years.
|
ParaGard® TCu380A
n=194 Participants
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Highly satisfied
|
364 Participants
|
92 Participants
|
|
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Satisfied
|
248 Participants
|
49 Participants
|
|
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Dissatisfied
|
118 Participants
|
43 Participants
|
|
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Highly dissatisfied
|
31 Participants
|
10 Participants
|
Adverse Events
Mona Lisa® NT Cu380 Mini
Serious events: 32 serious events
Other events: 742 other events
Deaths: 0 deaths
ParaGard® TCu380A
Serious events: 3 serious events
Other events: 183 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mona Lisa® NT Cu380 Mini
n=875 participants at risk；n=887 participants at risk
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Mona Lisa® NT Cu380 Mini: Mona Lisa® NT Cu380 Mini
|
ParaGard® TCu380A
n=213 participants at risk；n=218 participants at risk
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Infections and infestations
appendicitis
|
0.90%
8/887 • Number of events 8 • 3 years
|
0.00%
0/218 • 3 years
|
|
Infections and infestations
pyelonephritis
|
0.45%
4/887 • Number of events 4 • 3 years
|
0.00%
0/218 • 3 years
|
|
Infections and infestations
infected bite
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Infections and infestations
tubo-ovarian abscess
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
enteritis
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
food poisoning
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
gastrointestinal pain
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
inflammatory bowel disease
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
oesophageal achalasia
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Gastrointestinal disorders
oesophagitis
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Psychiatric disorders
suicidal ideation
|
0.23%
2/887 • Number of events 2 • 3 years
|
0.00%
0/218 • 3 years
|
|
Psychiatric disorders
suicidal attempt
|
0.23%
2/887 • Number of events 2 • 3 years
|
0.00%
0/218 • 3 years
|
|
Psychiatric disorders
dependence
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Psychiatric disorders
depression
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/887 • 3 years
|
0.46%
1/218 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
open fracture
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Injury, poisoning and procedural complications
overdose
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Injury, poisoning and procedural complications
uterine perforation
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Immune system disorders
anaphylactic reaction
|
0.23%
2/887 • Number of events 2 • 3 years
|
0.00%
0/218 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
ectopic pregnancy
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
premature delivery
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Surgical and medical procedures
appendicectomy
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Surgical and medical procedures
thyroid nodule removal
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Cardiac disorders
myocardial infarction
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
General disorders
non-cardiac chest pain
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Hepatobiliary disorders
cholecystitis
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Metabolism and nutrition disorders
diabetic ketoacidosis
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Reproductive system and breast disorders
ovarian mass
|
0.00%
0/887 • 3 years
|
0.46%
1/218 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/887 • 3 years
|
0.46%
1/218 • Number of events 1 • 3 years
|
|
Vascular disorders
pre-eclampsia
|
0.11%
1/887 • Number of events 1 • 3 years
|
0.00%
0/218 • 3 years
|
Other adverse events
| Measure |
Mona Lisa® NT Cu380 Mini
n=875 participants at risk；n=887 participants at risk
Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity.
Mona Lisa® NT Cu380 Mini: Mona Lisa® NT Cu380 Mini
|
ParaGard® TCu380A
n=213 participants at risk；n=218 participants at risk
ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity.
ParaGard® TCu380A: ParaGard® TCu380A
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
7.0%
61/875 • Number of events 80 • 3 years
|
7.5%
16/213 • Number of events 23 • 3 years
|
|
Infections and infestations
bacterial vaginosis
|
5.5%
48/875 • Number of events 60 • 3 years
|
5.2%
11/213 • Number of events 12 • 3 years
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
44.6%
390/875 • Number of events 494 • 3 years
|
46.9%
100/213 • Number of events 123 • 3 years
|
|
Reproductive system and breast disorders
menorrhagia
|
36.0%
315/875 • Number of events 477 • 3 years
|
38.5%
82/213 • Number of events 112 • 3 years
|
|
Reproductive system and breast disorders
metrorrhagia
|
28.6%
250/875 • Number of events 334 • 3 years
|
25.4%
54/213 • Number of events 61 • 3 years
|
|
Reproductive system and breast disorders
pelvic pain
|
21.3%
186/875 • Number of events 246 • 3 years
|
21.6%
46/213 • Number of events 48 • 3 years
|
|
Reproductive system and breast disorders
uterine spasm
|
8.1%
71/875 • Number of events 101 • 3 years
|
10.3%
22/213 • Number of events 34 • 3 years
|
|
Reproductive system and breast disorders
dyspareunia
|
7.0%
61/875 • Number of events 64 • 3 years
|
3.8%
8/213 • Number of events 8 • 3 years
|
|
Injury, poisoning and procedural complications
procedural pain
|
58.4%
511/875 • Number of events 574 • 3 years
|
63.4%
135/213 • Number of events 150 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place