Healthy WomenPhase 3NCT03124160
Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
A Phase 3 study testing Mona Lisa® NT Cu380 Mini and ParaGard® TCu380A in people with Healthy Women and Female Contraception, run by FHI 360 at 16 sites in United States.
Trial summary
This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women, Female Contraception
- What is being tested?
- Mona Lisa® NT Cu380 Mini and ParaGard® TCu380A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,105 participants
- Where
- 16 sitesUnited States
- Study dates
- 26 May 2017to 6 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-40 years
- o 16 and 17 year olds, where permissible by state regulations and local Institutional Review Board (IRB) approval
- Sexually active, anticipating at least one act of vaginal intercourse per menstrual cycle with a male partner and at risk for pregnancy
- seeking contraception, and willing to use the study IUD as the only contraception method
- willing to be randomized to one of the two copper IUDs
- has an intact uterus and at least one ovary
Show all 10Show fewer
- has a history of regular menstrual cycles; defined as occurring every 21-35 days when not using hormones, and with a variation of typical cycle length of no more than 5 days
- able and willing to provide written informed consent
- agrees to follow all study requirements
- not currently pregnant or at risk for luteal phase pregnancy based on history of unprotected intercourse
Who cannot join
- abnormal Pap requiring treatment after enrollment
- known human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) infection
- intending to become pregnant in the 37 months after enrollment
- known infertility
- history of allergy or sensitivity to copper
- previous tubal sterilization
Show all 34Show fewer
- has received an injectable contraceptive in the last 9 months and has not resumed regular menstrual cycles (as evidenced by 2 spontaneous menses)
- within 30 days of administration of mifepristone and/or misoprostol for medical abortion or for miscarriage management
- within 30 days of first, second, or third trimester abortion or miscarriage (note: potential abortion/miscarriage participants can be screened and return after 30 days for randomization and IUD insertion)
- within 30 days of delivery (for parous population)
- breastfeeding or recently breastfeeding women unless two consecutive normal menstrual periods have occurred after delivery and prior to enrollment.
- wants to use a copper IUD for emergency contraception
- has previously participated in the study
- participated in another clinical trial involving an investigational product within the last 30 days (before screening) or planning to participate in another clinical trial involving an intervention or treatment during this study
- not living in the catchment area of the study site or planning to move from the area within the year (unless known to be moving to the catchment area of another study site)
- known or suspected current alcohol or drug abuse
- planning to undergo major surgery during study participation
- current need for use of exogenous hormones or therapeutic anticoagulants (Note: subjects who start a therapeutic anticoagulant after enrolment will be allowed to continue in the study.)
- at high risk for sexually-transmitted infections or pelvic infection
- anticipated need for regular condom use (refer to Section 8.1).
- has any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe or complicate data interpretation
- Reported medical contraindications (Medical Eligibility Criteria category 3 or 4)14 to copper IUDs, including:
- suspicious unexplained vaginal bleeding
- known cervical cancer
- known endometrial cancer
- known Wilson's disease
- Confirmed gestational trophoblastic disease with persistently elevated beta-hCG levels or malignant disease, with evidence or suspicion of intrauterine disease
- anatomic abnormalities with distorted uterine cavity
- current pelvic inflammatory disease (PID)
- pelvic tuberculosis
- immediately post-septic abortion or puerperal sepsis
- current known purulent cervicitis or chlamydial infection or gonorrhea; Note: to enroll, there must be no obvious signs of infection at the time of enrollment based on pelvic exam. If lab results come back for positive infection after enrollment, treatment should be provided but the IUD can be left in place.
- complicated solid organ transplantation
- systemic lupus erythematosus with severe thrombocytopenia
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Boston Medical Center Corporation
Boston, Massachusetts, 02118
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
University of Cincinnati
Cincinnati, Ohio, 45267
University of Colorado
Denver, Colorado, 80045
University of Hawaii
Honolulu, Hawaii, 96826
Essential Access Health
Los Angeles, California, 90010
Planned Parenthood of New York
New York, New York, 10012
Columbia University
New York, New York, 10032
Eastern Virginia Medical School
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
University of California, Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84106
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard.
Read the detailed description
The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up.
Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call.
Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan.
- Conditions
- Healthy Women, Female Contraception
- Being tested
- Mona Lisa® NT Cu380 Mini, ParaGard® TCu380A
- Keywords
- Healthy Women, Female Contraception, IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mona Lisa® NT Cu380 MiniDrug
Also called NT380-Mini, NTCu380-Mini
copper intrauterine device
ParaGard® TCu380ADrug
Also called T380
copper intrauterine device
| Study group | Role | What they receive |
|---|---|---|
| Mona Lisa® NT Cu380 Mini | Experimental | Mona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity. Receives: Drug: Mona Lisa® NT Cu380 Mini |
| ParaGard® TCu380A | Active comparator | ParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity. Receives: Drug: ParaGard® TCu380A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
Measured: 3 years
Secondary outcomes (10)
IUD Continuation
IUD continuation at 36-months by product
Measured: 3 years
Failed IUD Insertion
Failed IUD insertion as measured by inability to place the IUD correctly
Measured: Immediate after IUD insertion attempt
Uterine Perforation
Uterine perforation as measured by ultrasound
Measured: 3 years
IUD Expulsion (Complete and Partial)
When the IUD is expelled from the uterus, either completely or partially.
Measured: 3 years
Vaginal Bleeding Patterns
Proportion of cycles with heavy bleeding (more than 4 sanitary products in a day)
Measured: 1 year
Pelvic Pain as Measured in the Subject Diary
Percent of cycles with any pelvic pain will be calculated using all available cycles
Measured: 1 year
Dysmenorrhea
Number of participants who experienced any dysmenorrhea during the trial
Measured: 3 years
Pain With and Shortly After Insertion as Recorded by Study Subjects
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
Measured: Pain level 10 minutes after IUD insertion
Ease of IUD Insertion as Recorded by the Investigator
Investigator to assess ease of IUD insertion (easy, somewhat easy, somewhat hard or hard)
Measured: Right after IUD insertion
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Overall product satisfaction level at exit visit (highly satisfied, satisfied, dissatisfied, highly dissatisfied)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start26 May 2017
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Premier Research
- Responsible party
- Sponsor
- Investigators
- Diana Blithe, Study director, National Institute of Child Health & Human Development (NICHD)David Hubacher, Study director, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124160
- Sponsor's protocol ID
- CCN016
- Status last verified
- Sep 2024
- First submitted
- 9 Feb 2017
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sivin I, Stern J. Long-acting, more effective copper T IUDs: a summary of U.S. experience, 1970-75. Stud Fam Plann. 1979 Oct;10(10):263-81. No abstract available.
PubMed 516121Sivin I, Tatum HJ. Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril. 1981 Aug;36(2):159-63.
PubMed 7262334Sivin I, Stern J, Coutinho E, Mattos CE, el Mahgoub S, Diaz S, Pavez M, Alvarez F, Brache V, Thevenin F, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS. Contraception. 1991 Nov;44(5):473-80. doi: 10.1016/0010-7824(91)90149-a.
PubMed 1797462The TCu380A, TCu220C, multiload 250 and Nova T IUDS at 3,5 and 7 years of use--results from three randomized multicentre trials. World Health Organization. Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods. Contraception. 1990 Aug;42(2):141-58.
PubMed 2085966Hubacher D. Copper intrauterine device use by nulliparous women: review of side effects. Contraception. 2007 Jun;75(6 Suppl):S8-11. doi: 10.1016/j.contraception.2006.12.005. Epub 2007 Feb 20.
PubMed 17531622Abraham M, Zhao Q, Peipert JF. Young Age, Nulliparity, and Continuation of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2015 Oct;126(4):823-829. doi: 10.1097/AOG.0000000000001036.
PubMed 26348177Benacerraf BR, Shipp TD, Lyons JG, Bromley B. Width of the normal uterine cavity in premenopausal women and effect of parity. Obstet Gynecol. 2010 Aug;116(2 Pt 1):305-310. doi: 10.1097/AOG.0b013e3181e6cc10.
PubMed 20664389Koch P, Reinhardt P, Soyka E. Intrauterine contraception using the Copper Mini-Gravigard 7 IUD: summary of 328 case histories. Contracept Deliv Syst. 1981 Apr;2(1):171-6.
PubMed 12336868Petersen KR, Brooks L, Jacobsen N, Skoby SO. Clinical performance of intrauterine devices in nulligravidae: is the length of the endometrial cavity of significance? Acta Eur Fertil. 1991 Jul-Aug;22(4):225-8.
PubMed 1844327Otero-Flores JB, Guerrero-Carreno FJ, Vazquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003 Apr;67(4):273-6. doi: 10.1016/s0010-7824(02)00519-x.
PubMed 12684147Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1257-81. doi: 10.1542/peds.2014-2300.
PubMed 25266435Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.
PubMed 22996129Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.
PubMed 27467196Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
PubMed 25601352Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992 Mar 28;339(8796):785-8. doi: 10.1016/0140-6736(92)91904-m.
PubMed 1347812
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-blind, Randomized Clinical Trial to Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard
- ClinicalTrials.gov ID
- NCT03124160
- Acronym / sponsor ID
- CCN016
- Conditions
- Healthy Women, Female Contraception
- Keywords
- Healthy Women, Female Contraception, IUD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,105 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Premier Research
- Study start
- 26 May 2017 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 1000 eligible participants in a 4:1 ratio to two different copper IUDs: 800 to Mona Lisa NT Cu380 Mini and 200 to ParaGard.
Detailed description
The total duration of the study for each participant is expected to be approximately 39 months: including screening and enrollment (up to 30 days to meet enrollment criteria), 37 months of participation, and a post-removal follow up telephone call 17 days post-removal. After enrollment, subject visits occur at 6 weeks, 3 months, 6 months, 12 months, 24 months, with telephone calls at 9, 18, and 30 months and seen again at 37 months for their final visit. Subjects will use a home pregnancy test 17 days post-removal of the IUD or Exit Visit procedures, whichever occurs first, and called by the site for the result and for safety follow-up.
Subject recruitment is expected to begin Q2 (in the second quarter of) 2017 and is planned to continue through Q2 2018. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q2 2021. The total duration of the study will be approximately 48 months for each study site including pre- and post- trial activities. The end of the study will occur when the last subject to be enrolled has completed her post-removal pregnancy test telephone call.
Total duration of the project is expected to be five years. Preliminary results of the study are expected to be available Q4 of 2019 based on the current study plan.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mona Lisa® NT Cu380 Mini | Experimental | Drug: Mona Lisa® NT Cu380 MiniMona Lisa® NT Cu380 Mini containing 380mm2 of copper surface inserted into the uterine cavity. |
| ParaGard® TCu380A | Active comparator | Drug: ParaGard® TCu380AParaGard® TCU380A containing 380mm2 of copper surface inserted into the uterine cavity. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 16-40 years
- o 16 and 17 year olds, where permissible by state regulations and local Institutional Review Board (IRB) approval
- Sexually active, anticipating at least one act of vaginal intercourse per menstrual cycle with a male partner and at risk for pregnancy
- seeking contraception, and willing to use the study IUD as the only contraception method
- willing to be randomized to one of the two copper IUDs
Key exclusion criteria (34 listed)
- abnormal Pap requiring treatment after enrollment
- known human immunodeficiency virus / acquired immunodeficiency syndrome (HIV/AIDS) infection
- intending to become pregnant in the 37 months after enrollment
- known infertility
- history of allergy or sensitivity to copper
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mona Lisa® NT Cu380 MiniAlso: NT380-Mini, NTCu380-Minicopper intrauterine device | Drug | Mona Lisa® NT Cu380 Mini |
| ParaGard® TCu380AAlso: T380copper intrauterine device | Drug | ParaGard® TCu380A |
Primary outcome
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years
Time frame: 3 years
Pearl Index is a measure of contraceptive efficacy used by the FDA that summarizes number of method failures per 100 person years
10 secondary outcomes
IUD Continuation
Time frame: 3 years
Failed IUD Insertion
Time frame: Immediate after IUD insertion attempt
Uterine Perforation
Time frame: 3 years
IUD Expulsion (Complete and Partial)
Time frame: 3 years
Vaginal Bleeding Patterns
Time frame: 1 year
Pelvic Pain as Measured in the Subject Diary
Time frame: 1 year
Dysmenorrhea
Time frame: 3 years
Pain With and Shortly After Insertion as Recorded by Study Subjects
Time frame: Pain level 10 minutes after IUD insertion
Ease of IUD Insertion as Recorded by the Investigator
Time frame: Right after IUD insertion
Overall Product Satisfaction as Measured by Acceptability Questions Asked of Subjects
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 516121Sivin I, Stern J. Long-acting, more effective copper T IUDs: a summary of U.S. experience, 1970-75. Stud Fam Plann. 1979 Oct;10(10):263-81. No abstract available.
- Background: PubMed 7262334Sivin I, Tatum HJ. Four years of experience with the TCu 380A intrauterine contraceptive device. Fertil Steril. 1981 Aug;36(2):159-63.
- Background: PubMed 1797462Sivin I, Stern J, Coutinho E, Mattos CE, el Mahgoub S, Diaz S, Pavez M, Alvarez F, Brache V, Thevenin F, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS. Contraception. 1991 Nov;44(5):473-80. doi: 10.1016/0010-7824(91)90149-a.
- Background: PubMed 2085966The TCu380A, TCu220C, multiload 250 and Nova T IUDS at 3,5 and 7 years of use--results from three randomized multicentre trials. World Health Organization. Special Programme of Research, Development and Research Training in Human Reproduction: Task Force on the Safety and Efficacy of Fertility Regulating Methods. Contraception. 1990 Aug;42(2):141-58.
- Background: PubMed 17531622Hubacher D. Copper intrauterine device use by nulliparous women: review of side effects. Contraception. 2007 Jun;75(6 Suppl):S8-11. doi: 10.1016/j.contraception.2006.12.005. Epub 2007 Feb 20.
- Background: PubMed 26348177Abraham M, Zhao Q, Peipert JF. Young Age, Nulliparity, and Continuation of Long-Acting Reversible Contraceptive Methods. Obstet Gynecol. 2015 Oct;126(4):823-829. doi: 10.1097/AOG.0000000000001036.
- Background: PubMed 20664389Benacerraf BR, Shipp TD, Lyons JG, Bromley B. Width of the normal uterine cavity in premenopausal women and effect of parity. Obstet Gynecol. 2010 Aug;116(2 Pt 1):305-310. doi: 10.1097/AOG.0b013e3181e6cc10.
- Background: PubMed 12336868Koch P, Reinhardt P, Soyka E. Intrauterine contraception using the Copper Mini-Gravigard 7 IUD: summary of 328 case histories. Contracept Deliv Syst. 1981 Apr;2(1):171-6.
- Background: PubMed 1844327Petersen KR, Brooks L, Jacobsen N, Skoby SO. Clinical performance of intrauterine devices in nulligravidae: is the length of the endometrial cavity of significance? Acta Eur Fertil. 1991 Jul-Aug;22(4):225-8.
- Background: PubMed 12684147Otero-Flores JB, Guerrero-Carreno FJ, Vazquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003 Apr;67(4):273-6. doi: 10.1016/s0010-7824(02)00519-x.
- Background: PubMed 25266435Ott MA, Sucato GS; Committee on Adolescence. Contraception for adolescents. Pediatrics. 2014 Oct;134(4):e1257-81. doi: 10.1542/peds.2014-2300.
- Background: PubMed 22996129Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.
- NDA for Paragard (TCu380A)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Blithe study director
National Institute of Child Health & Human Development (NICHD)
David Hubacher study director
FHI 360
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mona Lisa® NT Cu380 Mini and ParaGard® TCu380A in people with Healthy Women and Female Contraception, run by FHI 360 at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate of Mona Lisa Copper IUD Over 3 Years (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124160, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.