NCT03463252RecruitingPhase 2/3
Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma
Source: ClinicalTrials.gov · Last updated 13 Sept 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 4 Mar 2018
- Start date
- 1 Apr 2018
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- West China Second University Hospital
- Diseases
- Endometrial cancer, Childhood cancers
- NCT number
- NCT03463252
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 224
- From 1 Apr 2018 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 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 have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
- 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)
Other
- Patients have contraindications for pregnancy;
- Patients refuse to participate in clinical follow-up or sign the informed consent form.
- For Patients With Endometrial atypical hyperplasia：
- Patients have contraindications for pregnancy
- Patients refuse to participate in clinical follow-up or sign the informed consent form.
Who the study is looking for
- ≤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.
- ≤ 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
Criteria the registry did not label
- For Patients With Endometrial Cancer：
Age in the registry: - to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Second University Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.