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

September 19, 2023 updated by: Memorial Sloan Kettering Cancer Center
Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States
        • Memorial Sloan Kettering Rockville Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women between 35 and 50 years of age (inclusive)
  • Women who will be scheduled to undergo an RRSO or RRs
  • Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
  • Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
  • Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)

Exclusion Criteria:

  • Any medical contraindication to use of a Mirena® IUD, including:

    • Pregnancy (a pregnancy test is required prior to study entry)
    • Known uterine anomaly that distorts the shape of the uterine cavity
    • Acute pelvic inflammatory disease
    • Postpartum endometritis or endometrial infection
    • Known or suspected uterine or cervical neoplasia
    • Known history or suspected breast cancer or other progestin-sensitive cancer
    • Uterine bleeding of unknown etiology.
    • Untreated acute cervicitis, vaginitis, or other lower genital tract infections
    • Acute liver disease or liver tumor (benign or malignant)
  • Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
  • Positive pregnancy test
  • Breastfeeding
  • Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirena® IUD
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.
Device: Mirena® intra-uterine device (IUD)
In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+
Time Frame: 1 year
Women will be deemed evaluable for this primary outcome if they successfully underwent placement of the Mirena® IUD, received a RRSO or RRS as planned, and had a P4 value ≤1 ng/ml.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Dennis Chi, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

December 29, 2022

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimated)

June 22, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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