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Progestin-releasing Intrauterine Device

Mirena® intra-uterine device (IUD) for Ovarian Cancer

Q: Are there currently open slots for this research endeavor?

Results on clinicaltrials.gov demonstrate that, since the trial's last update on July 18th 2022, this particular research study is not currently taking new participants. However, there are 431 other studies actively enlisting patients at present.

Q: Am I able to participate in this research initiative?

This medical trial is seeking 7 patients aged between 35 and 50 with carcinoma of the ovarian epithelium. Potential participants must also have a Mirena® Intrauterine Device (IUD) inserted prior to or at the time of their risk-reducing surgery, or already have one in place; this is in addition to using non-hormonal forms of contraception such as copper IUDs.

Q: Does the research team require participants to be of legal age?

According to the study's requirements, participants must be no younger than 35 and not older than 50.

Q: How prevalent is this trial in the local area?

This research study is accepting enrollees at 6 different sites, including Memorial Sloan Kettering Westchester in Harrison, Memorial Sloan Kettering Commack in Commack and the Memorial Sloan Kettering Monmouth facility in Middletown.

N/A

Waitlist Available

Led By Dennis Chi, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is looking at whether the Mirena IUD reduces cell proliferation in the fallopian tube fimbriae as a possible marker of protection against ovarian cancer.

Eligible Conditions

Ovarian Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mirena® IUDExperimental Treatment1 Intervention

This is a non-randomized study of the effect of Mirena® IUD use of at least 10 days before an RRSO or RRS on cell proliferation within the FTF and when available within ovarian CICs in women aged 35 through 50. The study will compare the results from 14 women using Mirena® with the results from 28 normally cycling women identified under MSK IRB Protocol #14-165 described above; all patients will be aged 35-50 years, and will have undergone the RRSO at MSK. To date we have identified approximately 100 suitable controls and are continuing to identify further suitable controls among women who have recently undergone RRSOs at MSK. The balancing/matching factors will be BRCA status (BRCA1/BRCA2/BRCA-ve), age (35-39/40-44/45-50), parity (nulliparous/parous), and BMI (<30/30+ kg/m^2). As each Mirena® patient completes the study and is deemed evaluable, she will be matched on each of these factors with 2 controls.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirena® intra-uterine device (IUD)

2015

N/A

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,343 Total Patients Enrolled

73 Trials studying Ovarian Cancer

42,968 Patients Enrolled for Ovarian Cancer

Dennis Chi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

6 Previous Clinical Trials

456 Total Patients Enrolled

4 Trials studying Ovarian Cancer

310 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently open slots for this research endeavor?

"Results on clinicaltrials.gov demonstrate that, since the trial's last update on July 18th 2022, this particular research study is not currently taking new participants. However, there are 431 other studies actively enlisting patients at present."

Answered by AI

Am I able to participate in this research initiative?

"This medical trial is seeking 7 patients aged between 35 and 50 with carcinoma of the ovarian epithelium. Potential participants must also have a Mirena® Intrauterine Device (IUD) inserted prior to or at the time of their risk-reducing surgery, or already have one in place; this is in addition to using non-hormonal forms of contraception such as copper IUDs."

Answered by AI

Does the research team require participants to be of legal age?

"According to the study's requirements, participants must be no younger than 35 and not older than 50."

Answered by AI

How prevalent is this trial in the local area?

"This research study is accepting enrollees at 6 different sites, including Memorial Sloan Kettering Westchester in Harrison, Memorial Sloan Kettering Commack in Commack and the Memorial Sloan Kettering Monmouth facility in Middletown."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation

2015. "Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02477202.