Impact of promestriene on hysteroscopy complications in postmenopausal wome

Phase 3

• Conditions: N90.5; N95.2; Cervix narrowing and stenosis; Accidental cut, puncture, perforation or hemorrhage during endoscopic examination; Vulvar atrophy; Postmenopausal atrophic vaginitis

• Registration Number: RBR-1044h6fh
• Lead Sponsor: Hospital da Baleia/Fundação Benjamin Guimarães

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Study Completion: 2023-02-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

postmenopausal women; with indication of surgical hysteroscopy; patients of the Hospital da Baleia

Exclusion Criteria

Patients who refuse to participate, not signing the consent form; Patients who do not make adequate use of promestriene; Previous attempt at surgical hysteroscopy with complication; Patients with a personal history of breast, ovarian or endometrial cancer; Patients already using hormone therapy; Known hypersensitivity to promestriene or any component of the formulation; Exclusion criteria for the promestriene group: patients with other diseases that contraindicates the use of estrogen (unexplained vaginal bleeding, severe active liver disease, coronary heart disease, stroke, dementia, high risk of venous thromboembolic disease, porphyria cutanea tarda, hypertriglyceridemia and patients with whom there is concern about endometriosis reactivation, possibility of migraine worsening or possibility of leiomyoma growth). These patients will be will be allocated in the placebo group without randomization

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of intraoperative complications in each group (intervention group and placebo group), verified through the review of the participants' operative bulletin. We will see if there is a reduction in the percentage of complications with the use of promestriene

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes are expected