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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477202
• Other study ID #: 15-105
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 29, 2022

Study information

• Verified date: January 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 29, 2022
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer

Intervention

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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center