Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Phase 4

Completed

• Conditions: Pelvic Organ Prolapse; Vaginitis Atropic; Endometrial Hyperplasia
• Interventions: Drug: Conjugated Estrogen; Drug: Promestriene; Drug: Estriol; Drug: Vaginal Moisturizer - Cream

• Registration Number: NCT03032848
• Lead Sponsor: Universidade Federal do Paraná

Brief Summary

To evaluate the difference of three vaginal estrogens creams comparative with placebo on improvement of hormonal cytology, local and systemic climacteric complaints, as well as its endometrial security.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-26
• Primary Completion: 2016-12-20
• Study Completion: 2016-12-26
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

• post menopause women
• normal oncotic cytology and mammogram
• any grade of pelvic organ prolapse with surgery indication and ultrasound with endometrium measure less than 5 mm

Exclusion Criteria

• vaginal bleeding
• hormonal replacement on the past three months
• renal or hepatic desease
• porfiria
• past venous thromboembolism; ulcerated prolapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated Estrogen Group	Estriol	use of 1 gram per day
Estriol Group	Vaginal Moisturizer - Cream	use of 1 gram per day
Vaginal Moisturizer Cream	Conjugated Estrogen	use of 1 gram per day
Estriol Group	Conjugated Estrogen	use of 1 gram per day
Promestriene Group	Conjugated Estrogen	use of 1 gram per day
Promestriene Group	Vaginal Moisturizer - Cream	use of 1 gram per day
Vaginal Moisturizer Cream	Estriol	use of 1 gram per day
Conjugated Estrogen Group	Promestriene	use of 1 gram per day
Vaginal Moisturizer Cream	Promestriene	use of 1 gram per day
Conjugated Estrogen Group	Vaginal Moisturizer - Cream	use of 1 gram per day
Promestriene Group	Estriol	use of 1 gram per day
Estriol Group	Promestriene	use of 1 gram per day

Primary Outcome Measures

Name	Time	Method
Evaluate the histopathological effects on endometrium after each treatment	48 days	Compare the histopathological results after treatment on each group and among each other
Compare the endometrial thickness measured by ultrassound after each treatment	48 days	Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other

Secondary Outcome Measures

Name	Time	Method
Evaluate the changes of maturation index (Meisels Index) after each treatement	48 days	Compare the changes on Meisels Index after each treatment and among each other
Evaluate the changes on climacteric complaints after each treatment	48 days	Compare the changes on systemic and genital complaints after each treatment, and among each other