drugset / Trial / NCT03620929

Estrogen in the Prevention of Adhesion Reformation

NCT03620929

Phase 4 Unknown 186 enrolled Fu Xing Hospital, Capital Medical University
RandomizedParallel-groupSingle-blindPrevention

Summary

Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium.It seems that the role of postoperative estrogen therapy in the prevention of recurrence of IU adhesions is still controversial. To investigate if estrogen therapy can prevent adhesion reformation after adhesiolysis. After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having estrogen after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days; and the control group without estrogen treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

Timeline

Start
2018-08-13
Primary completion
2018-08-13
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject estradiol valerate Unknown 4 mg
Background Dydrogesterone Other / unclassified 10 mg

Indications