Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

University of Cagliari

Status and phase: Unknown; Phase 4

Conditions: Uterine Fibroids

Treatments: Drug: Ulipristal acetate; Drug: Dienogest; Procedure: operative hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02440750

HYSTERO

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion criteria

• pregnancy
• other hormonal therapy in the previous 8 weeks
• hepatic or renal impairment
• any medical condition that would increase the surgical risk
• refusal or unable to sign written consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Dienogest

Experimental group

Description:

Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die

Treatment:

Drug: Dienogest

Procedure: operative hysteroscopy

Ulipristal acetate

Experimental group

Description:

Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die

Treatment:

Procedure: operative hysteroscopy

Drug: Ulipristal acetate