Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03463252

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

West China Second University Hospital

Chengdu, Sichuan, 610000, China

Location status: Recruiting

Location contact

Zheng Ying, professor

CONTACT

[email protected]

+8613018256012

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For Patients With Endometrial Cancer:

Inclusion criteria

  • ≤40 years of age:
  • 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);
  • Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.

Exclusion criteria

  • 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);
  • Patients refuse to participate in clinical follow-up or sign the informed consent form.

For Patients With Endometrial atypical hyperplasia:

Inclusion criteria

  • ≤ 40 years of age
  • Having a strong desire for fertility preservation
  • Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
  • Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up

Exclusion criteria

  • Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
  • Patients have contraindications for pregnancy
  • Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
  • Patients refuse to participate in clinical follow-up or sign the informed consent form.

Treatment and study plan

Progesterone

Drug

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

Other names: medroxyprogesterone acetate (MPA)

Mirena®

Device

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

Other names: LNG-IUS

GnRH agonist

Drug

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

Other names: GnRH-a

Primary outcomes

  1. Pathologic Response

    Time frame: 6-12 months

    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.

  2. Pregnancy Rate

    Time frame: 7-144 months

    The percentage of successful pregnancies in the CR patients.

  3. Live Birth Rate

    Time frame: 16-144 months

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

Secondary outcomes

  1. Side-Affects Rate

    Time frame: 1-144 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

CHEN Si Jing, postgraduate

CONTACT

[email protected]

+86218380361314

ZHENG Ying, Professor

CONTACT

[email protected]

+8613018256012

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Mar 13, 2018
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.