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New treatment option for Endometrial Cancer
Official title Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC
ClinicalTrials.gov ID: NCT03463252
What this study is testing
What is Progesterone?
Progesterone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial cancer.
Also referred to as medroxyprogesterone acetate (MPA).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 40, women only
You may be able to join if
- For Patients With Endometrial Cancer：
- ≤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...
- Disease limited to the endometrium (stage 1A) on MRI;
You likely can't join if
- Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved...
- 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...
- Patients refuse to participate in clinical follow-up or sign the informed consent form. For Patients With Endometrial atypical hyperplasia： Inclusion...
- ≤ 40 years of age
See the full eligibility criteria
- For Patients With Endometrial Cancer：
- ≤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...
- 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...
- 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...
- Patients refuse to participate in clinical follow-up or sign the informed consent form.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, up to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.