NCT02440750

Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
PROCEDURE	operative hysteroscopy	Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
DRUG	Dienogest	21 days administration of dienogest 2 mg/die
DRUG	Ulipristal acetate	21 days administration of ulipristal acetate 5 mg/die

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2015-05-12
• Last updated: 2016-03-09