drugset / Trial / NCT03992937
Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
Timeline
- Start
- 2019-06-20
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
Outcome
Missed primary endpoint
paper The regression rate was not significantly different between the groups (95.8% with LNG-IUS vs. 90.8% with VMP; P = 0.194). PMID 36527262 ↗
Publications
- Background Tasci Y, Polat OG, Ozdogan S, Karcaaltincaba D, Seckin L, Erkaya S. Comparison of the efficacy of micronized progesterone and lynestrenol in treatment of simple endometrial hyperplasia without atypia. Arch Gynecol Obstet. 2014 Jul;290(1):83-6. doi: 10.1007/s00404-014-3161-4. Epub 2014 Feb 1.
- Gezer S, Kole E, Aksoy L. Vaginal micronized progesterone versus the levonorgestrel-releasing intrauterine system for treatment of non-atypical endometrial hyperplasia: A randomized controlled trial. Int J Gynaecol Obstet. 2023 May;161(2):661-666. doi: 10.1002/ijgo.14632. Epub 2023 Jan 12.
- Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Progesterone | Other / unclassified | 200 mg | Other |