Clinical trial NCT02477202: Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Official title: Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: Mirena® IUD's
Women
risk-reducing salpingo-oophorectomy
risk-reducing salpingectomy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 7
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Chi, MD
role: PRINCIPAL_INVESTIGATOR
References: