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

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ClinicalTrials.gov Identifier: NCT02477202
Recruitment Status : Active, not recruiting
First Posted : June 22, 2015
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Device: Mirena® intra-uterine device (IUD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


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).




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477202


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Dennis Chi, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02477202     History of Changes
Other Study ID Numbers: 15-105
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
Mirena® IUD's
Women
risk-reducing salpingo-oophorectomy
risk-reducing salpingectomy

Additional relevant MeSH terms:
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Levonorgestrel
Carcinoma, Ovarian Epithelial
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral