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

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

No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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