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

Status:	Active, not recruiting
Conditions:	Ovarian Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	35 - 50
Updated:	4/29/2018
Start Date:	June 2015
End Date:	June 2019

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.

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

We found this trial at

sites

Memoral Sloan Kettering Basking Ridge

136 Mountainview Boulevard
Basking Ridge, New Jersey 07920

Phone: 212-639-5016

from

Basking Ridge, NJ