Trial · NCT03124160

Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

NCT03124160, Phase 3, Completed, FHI 360; results first posted 2024-09-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard. Trials, record NCT03124160. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03124160

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
NCT number: NCT03124160
Status: Completed
Phases: Phase 3
Enrollment: 1,105 participants, actual
Lead sponsor: FHI 360
Conditions: Healthy Women, Female Contraception
Interventions: Mona Lisa® NT Cu380 Mini, ParaGard® TCu380A
First posted: 2017-04-21
Last updated: 2024-09-25
Results first posted: 2024-09-25

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years	3 years	Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
Secondary	IUD Continuation	3 years	IUD continuation at 36-months by product
Secondary	Failed IUD Insertion	Immediate after IUD insertion attempt	Failed IUD insertion as measured by inability to place the IUD correctly
Secondary	Uterine Perforation	3 years	Uterine perforation as measured by ultrasound
Secondary	IUD Expulsion (Complete and Partial)	3 years	When the IUD is expelled from the uterus, either completely or partially.
Secondary	Vaginal Bleeding Patterns	1 year	Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
Secondary	Pelvic Pain as Measured in the Subject Diary	1 year	Percent of cycles with any pelvic pain will be calculated using all available cycles
Secondary	Dysmenorrhea	3 years	Number of participants who experienced any dysmenorrhea during the trial
Secondary	Pain With and Shortly After Insertion as Recorded by Study Subjects	Pain level 10 minutes after IUD insertion	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
Secondary	Ease of IUD Insertion as Recorded by the Investigator	Right after IUD insertion	Investigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years	3 years	includes only participants with an evaluable cycle for estimating efficacy	Pearl Index = Num preg per 100 person yr	NUMBER
SECONDARY	IUD Continuation	3 years	Participants with successful IUD insertion	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Failed IUD Insertion	Immediate after IUD insertion attempt	Treated population: uterus was successfully sounded and IUD insertion attempt was made	participants	NUMBER
SECONDARY	Uterine Perforation	3 years	User population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	IUD Expulsion (Complete and Partial)	3 years	user population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Vaginal Bleeding Patterns	1 year	User population with evaluable cycles	percent	MEAN
SECONDARY	Pelvic Pain as Measured in the Subject Diary	1 year		percent	NUMBER
SECONDARY	Dysmenorrhea	3 years	User population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pain With and Shortly After Insertion as Recorded by Study Subjects	Pain level 10 minutes after IUD insertion	User population	units on a scale	MEAN
SECONDARY	Ease of IUD Insertion as Recorded by the Investigator	Right after IUD insertion		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years	Mona Lisa NT Cu380 Mini Participants <36 Years of Age	1.86	95% Confidence Interval 1.20 to 2.74	Pearl Index = Num preg per 100 person yr
IUD Continuation	Mona Lisa® NT Cu380 Mini	426		Participants
IUD Continuation	ParaGard® TCu380A	91		Participants
Failed IUD Insertion	Mona Lisa® NT Cu380 Mini	1		participants
Failed IUD Insertion	ParaGard® TCu380A	1		participants
Uterine Perforation	Mona Lisa® NT Cu380 Mini	1		Participants
Uterine Perforation	ParaGard® TCu380A	0		Participants
IUD Expulsion (Complete and Partial)	Mona Lisa® NT Cu380 Mini	66		Participants
IUD Expulsion (Complete and Partial)	ParaGard® TCu380A	22		Participants
Vaginal Bleeding Patterns	Mona Lisa® NT Cu380 Mini	54.4	95% Confidence Interval 53.43 to 55.46	percent

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mona Lisa® NT Cu380 Mini	887
Overall Study	STARTED	ParaGard® TCu380A	218
Overall Study	COMPLETED	Mona Lisa® NT Cu380 Mini	426
Overall Study	COMPLETED	ParaGard® TCu380A	91
Overall Study	NOT COMPLETED	Mona Lisa® NT Cu380 Mini	461
Overall Study	NOT COMPLETED	ParaGard® TCu380A	127

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	dysmenorrhoea	Reproductive system and breast disorders	Mona Lisa® NT Cu380 Mini	390	875	494
other	dysmenorrhoea	Reproductive system and breast disorders	ParaGard® TCu380A	100	213	123
other	menorrhagia	Reproductive system and breast disorders	Mona Lisa® NT Cu380 Mini	315	875	477
other	menorrhagia	Reproductive system and breast disorders	ParaGard® TCu380A	82	213	112
other	metrorrhagia	Reproductive system and breast disorders	Mona Lisa® NT Cu380 Mini	250	875	334
other	metrorrhagia	Reproductive system and breast disorders	ParaGard® TCu380A	54	213	61
other	pelvic pain	Reproductive system and breast disorders	Mona Lisa® NT Cu380 Mini	186	875	246
other	pelvic pain	Reproductive system and breast disorders	ParaGard® TCu380A	46	213	48
other	uterine spasm	Reproductive system and breast disorders	Mona Lisa® NT Cu380 Mini	71	875	101
other	uterine spasm	Reproductive system and breast disorders	ParaGard® TCu380A	22	213	34

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mona Lisa® NT Cu380 Mini	0	887
Total, all-cause mortality	ParaGard® TCu380A	0	218
Total, other adverse events	Mona Lisa® NT Cu380 Mini	742	875
Total, other adverse events	ParaGard® TCu380A	183	213
Total, serious adverse events	Mona Lisa® NT Cu380 Mini	32	887
Total, serious adverse events	ParaGard® TCu380A	3	218

Source ClinicalTrials.gov

Papers17

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
516121	BACKGROUND	PubMed
1347812	BACKGROUND	PubMed
1797462	BACKGROUND	PubMed
1844327	BACKGROUND	PubMed
2085966	BACKGROUND	PubMed
7262334	BACKGROUND	PubMed
12336868	BACKGROUND	PubMed
12684147	BACKGROUND	PubMed
17531622	BACKGROUND	PubMed
20664389	BACKGROUND	PubMed

1 to 10 of 17

See all 17 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: Uterine Perforation	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: Dysmenorrhea	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: IUD Expulsion (Complete and Partial)	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: deaths from any cause	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: Failed IUD Insertion	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: IUD Continuation	Trial comparisons
Mona Lisa® NT Cu380 Mini vs ParaGard® TCu380A: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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