Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

Universidade Federal do Paraná

Status and phase: Completed; Phase 4

Conditions: Vaginitis Atropic; Pelvic Organ Prolapse; Endometrial Hyperplasia

Treatments: Drug: Vaginal Moisturizer - Cream; Drug: Conjugated Estrogen; Drug: Estriol; Drug: Promestriene

Study type: Interventional

Funder types: Other

Identifiers

NCT03032848

23286013.7.0000.0096

475.622 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 4 patient groups, including a placebo group

Conjugated Estrogen Group

Active Comparator group

Description:

use of 1 gram per day

Treatment:

Drug: Promestriene

Drug: Estriol

Drug: Vaginal Moisturizer - Cream

Promestriene Group

Active Comparator group

Description:

use of 1 gram per day

Treatment:

Drug: Estriol

Drug: Conjugated Estrogen

Drug: Vaginal Moisturizer - Cream

Estriol Group

Active Comparator group

Description:

use of 1 gram per day

Treatment:

Drug: Promestriene

Drug: Conjugated Estrogen

Drug: Vaginal Moisturizer - Cream

Vaginal Moisturizer Cream

Placebo Comparator group

Description:

use of 1 gram per day

Treatment:

Drug: Promestriene

Drug: Estriol

Drug: Conjugated Estrogen