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Clinical trial

The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

ID
Name
DROVZOEFFIPREP
Description
The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-08-01
Trial end
2024-03-01
Status
Completed
Phase
Early phase I
Treatment
Drospirenone / Estetrol
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle
Arms:
Drospirenone/Estetrol
Nomegestrol Acetate / Estradiol
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle
Arms:
Nomegestrol Acetate/Estradiol
Ethinylestradiol / Dienogest
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle
Arms:
Ethinylestradiol/Dienogest
Size
150
Primary endpoint
Quality of endometrial preparation
14th day of treatment
Eligibility criteria
Inclusion Criteria: * Patients with endometrial polyps. Exclusion Criteria: * Patients with other endometrial pathologies.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2024-04-08

1 organization

3 products

2 indications

Organization
University of Palermo
Product
Drospirenone + Estetrol
Indication
Endometrial Polyp
Indication
Endometrial Diseases
Product
Nomegestrol Acetate + Estradiol
Product
Ethinylestradiol + Dienogest