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Trial record 34 of 403 for:    LEVONORGESTREL

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 : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 22, 2015
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2015)
number of women who have a P4 value ≤1 ng/ml [ 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 as planned, and had a P4 value ≤1 ng/ml.
Change History Complete list of historical versions of study NCT02477202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Official Title  ICMJE Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epithelial Ovarian Cancer
Intervention  ICMJE 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).
Study Arms  ICMJE 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.
Intervention: Device: Mirena® intra-uterine device (IUD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 25, 2018)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2015)
14
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02477202
Other Study ID Numbers  ICMJE 15-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Chi, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP