Health TrialsbyHealthPanel

Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

ConditionsEndometrial CancerAtypical Endometrial Hyperplasia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
AgeUp to 40
SponsorWest China Second University Hospital

About this trial

Primary end points:

This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.

Second end points:

To analyze the appearances of side-effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Having a strong desire for fertility preservation;

Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;

Disease limited to the endometrium (stage 1A) on MRI;

Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);

Disqualifiers

Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;

Patients have lynch syndrome (LS);

Patients have contraindications for pregnancy;

Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Progesterone

    Drug

    MPA oral 250mg-500mg qd for 3 months per cycle

  • Mirena®

    Device

    levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle

  • GnRH agonist

    Drug

    GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle

Treatment groups

224 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: MPA for EC without progesterone contraindicationActive comparator 1 intervention
Group B: MPA+Mirena® for EC without contraindicationExperimental treatment 2 interventions
Group C: Mirena® for EC without contraindicationExperimental treatment 1 intervention
Group D: GnRH agonist+Mirena® for EC with contraindicationActive comparator 2 interventions
Group E: Mirena® for EC with contraindicationExperimental treatment 1 intervention
Group F: Mirena® for EAH without progesterone contraindicationActive comparator 1 intervention
Group G: MPA for EAH without progesterone contraindicationExperimental treatment 1 intervention
Group H: Mirena® for EAH with progesterone contraindicationActive comparator 1 intervention
Group I: GnRH-a+Mirena® for EAH with progesterone contraindicationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathologic Response

Pathologic response to medicine treatment is categorized as complete response (CR), partial response (PR), no change (NC), and progressive disease (PD). CR is defined as the absence of any hyperplastic or cancerous lesion. PR is defined as the residual lesion with degeneration and atrophy of endometrial glands. NC is defined as residual lesion without degeneration or atrophy of endometrial glands. PD is defined as the appearance of endometrial cancer for EAH and grade 2 (G2) or 3 for EC.

Time frame
6-12 months
2

Pregnancy Rate

The percentage of successful pregnancies in the CR patients.

Time frame
7-144 months
3

Live Birth Rate

The percentage of successfully alive baby delivery in the pregnant patients.

Time frame
16-144 months

Secondary outcomes

1

Side-Affects Rate

The appearances of side-effects include weight gain, irregular vaginal bleeding, breast pain, appetite changes, nausea, vomiting, rash, jaundice, thromboembolism, hypertension, liver dysfunction, kidney dysfunction, glucose intolerance, and diabetes.

Time frame
1-144 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Second University Hospital

Lead sponsor

Source ClinicalTrials.gov
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