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

Not Applicable

Completed

• Conditions: Epithelial Ovarian Cancer
• Interventions: Device: Mirena® intra-uterine device (IUD)

• Registration Number: NCT02477202
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-22
• Primary Completion: 2022-12-29
• Study Completion: 2022-12-29
• Status Verified: 2023-01
• Results First Submitted: 2023-09-19
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirena® IUD	Mirena® intra-uterine device (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.

Primary Outcome Measures

Name	Time	Method
Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+	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.

Trial Locations

Locations (6)

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Rockville Centre; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States