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Could a hormonal IUD replace surgery for some uterine cancers?

NCT ID NCT02397083

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study looks at whether a hormonal intrauterine device (IUD) alone or combined with the drug everolimus can treat precancerous changes or very early-stage endometrial cancer. About 100 women with these conditions will receive the IUD, and some will also take everolimus if the IUD alone doesn't work. The goal is to control or shrink the abnormal cells, potentially avoiding more invasive treatments like surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Sep 2015

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All patients with a diagnosis of complex atypical hyperplasia OR, grade 1 endometrioid OR focal grade 2 adenocarcinoma in predominately grade 1 disease endometrial carcinoma on endometrial biopsy or dilation and curettage (D \& C) within three months of study enrollment * Patients with complex atypical hyperplasia OR grade 1 endometrioid adenocarcinoma with stable/persistent disease with LIUD already in place. LIUD must have been in place for at least 3 months * Prior progesterone treatment is ALLOWED, but a 28 day washout period is required before LIUD placement. If archival tissue is available from prior to any progesterone treatment, the washout period is not needed * Ability to comply with endometrial biopsies every 3 months * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Platelets \>= 100 x 10\^9/L * Hemoglobin (Hb) \> 9 g/dL * Total serum bilirubin =\< 2.0 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (ULN) * International normalized ratio (INR) =\< 2; factor 10A drawn if patient on anticoagulant Eliquis * Serum creatinine =\< 1.5 x ULN * Fasting serum cholesterol =\< 300 mg/dL OR =\< 7.75 mmol/L AND fasting triglycerides =\< 2.5 x ULN; NOTE: in case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication * Signed informed consent obtained prior to any screening procedures Exclusion Criteria: * Patients with grade 2-3 endometrioid, uterine serous, clear cell, mucinous, squamous, transitional cell, sarcomas, or carcinosarcoma histology * Evidence of extrauterine spread of disease on imaging or during surgical evaluation * Patients who have prior therapy with everolimus or any other mammalian target of rapamycin (mTOR) inhibitor * Patients currently receiving anticancer therapies (including chemotherapy, radiation therapy, hormonal, or antibody-based therapy); prior treatment should have a washout period of 28 days or 4 1/2 half-lives (7 days), whichever is shorter * Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus) * Known intolerance or hypersensitivity to progesterone or its excipients * Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus (e.g., inability to take oral medication or a requirement for intravenous \[IV\] alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, and active peptic ulcer disease) are excluded; subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded, as are any patients who cannot swallow the capsule whole * Uncontrolled diabetes mellitus as defined by glycosylated hemoglobin (HbA1c) \> 8% despite adequate therapy; patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary * Patients who have any severe and/or uncontrolled medical conditions such as: a) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction =\< 6 months prior to start of everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease; b) symptomatic congestive heart failure of New York Heart Association class III or IV; c) active (acute or chronic) or uncontrolled severe infection (not responding to antibiotics), liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis (i.e. quantifiable hepatitis B virus-deoxyribonucleic acid \[HBV-DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus-ribonucleic acid \[HCV-RNA\]); d) known severely impaired lung function (spirometry and diffusing capacity of the lung for carbon monoxide \[DLCO\] 50% or less of normal and oxygen \[O2\] saturation 88% or less at rest on room air); e) active, bleeding diathesis * Chronic treatment with corticosteroids or other immunosuppressive agents; topical or inhaled corticosteroids are allowed * Patients who have a known history of human immunodeficiency virus (HIV) seropositivity * Patients who have received live attenuated vaccines within 1 week of start of everolimus and during the study; patient should also avoid close contact with others who have received live attenuated vaccines; examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guerin (BCG), yellow fever, varicella and TY21a typhoid vaccines * Other malignancies within the past 3 years except for basal or squamous cell carcinoma of the skin * Active (acute or chronic) or uncontrolled severe infections (not responding to antibiotics), including acute pelvic inflammatory disease * Congenital or acquired uterine anomaly which distorts the uterine cavity * Genital actinomycosis * Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study * Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing * Women who are pregnant or nursing (lactating) women * Women of child-bearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must use one additional highly effective methods of contraception in addition to the LIUD during the study and 8 weeks after; acceptable effective contraception methods include combo of the following: a) barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository; b) total abstinence or; c) male/female sterilization; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation \> six weeks prior to randomization; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential * Women who are on contraindicated medications to everolimus must have confirmation from their physician that they may change or discontinue the medication if randomized to the LIUD + everolimus arm

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103, United States

  • Covenant HealthCare Mackinaw

    Saginaw, Michigan, 48604, United States

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967, United States

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • MD Anderson League City

    League City, Texas, 77573, United States

  • MD Anderson West Houston

    Houston, Texas, 77079, United States

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478, United States

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384, United States

  • McKee Medical Center

    Loveland, Colorado, 80539, United States

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024, United States

  • North Colorado Medical Center

    Greeley, Colorado, 80631, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • The Woman's Hospital of Texas

    Houston, Texas, 77054, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.