Trials / Recruiting
RecruitingNCT03463252
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
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- Sponsor
- West China Second University Hospital · Academic / Other
- Sex
- Female
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Progesterone | MPA oral 250mg-500mg qd for 3 months per cycle |
| DEVICE | Mirena® | levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle |
| DRUG | GnRH agonist | GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle |
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2025-12-30
- Completion
- 2030-12-30
- First posted
- 2018-03-13
- Last updated
- 2021-09-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03463252. Inclusion in this directory is not an endorsement.