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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epithelial Ovarian Cancer

Intervention: Mirena® intra-uterine device (IUD) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Dennis Chi, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Dennis Chi, MD, Phone: 212-639-5016

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: cell proliferation in the fallopian tube fimbriae as measured by Ki-67

Eligibility

Minimum age: 35 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women who are premenopausal between 35 and 45 years of age (inclusive)

- Women who are scheduled to undergo RRSO surgery days 5 through 15 of their menstrual

cycle (Note: the upper limit of 15 days is calculated based on a 28-day cycle; it needs to be reduced by one day for each day the subject's usual cycle length is < 28 days)

- Women who have at least one ovary and fallopian tube

- Women who have had regular normal monthly menstrual cycles for at least 3 months, the

last 3 of which do not differ in length by more than 4 days

- Women who were recently pregnant are eligible if they have had regular normal monthly

menstrual cycles for at least 3 months and are not breastfeeding

- Women who were recently on oral contraceptives or any form of IUD are eligible if

they have had regular normal monthly menstrual cycles for at least 3 months. 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 progesterone sensitive cancer

- Uterine bleeding of unknown etiology.

- Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months

- Positive pregnancy test

Locations and Contacts

Dennis Chi, MD, Phone: 212-639-5016

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States; Recruiting
Dennis Chi, MD, Phone: 212-639-5016

Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States; Recruiting
Dennis Chi, MD, Phone: 212-639-5016

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Dennis Chi, MD, Phone: 212-639-5016
Malcolm Pike, PhD, Phone: 646-888-8240
Dennis Chi, MD, Principal Investigator

Memorial Sloan Kettering West Harrison, West Harrison, New York 10604, United States; Recruiting
Dennis Chi, MD, Phone: 212-639-5016

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: June 2015
Last updated: August 6, 2015

Page last updated: August 23, 2015

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