Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

NCT ID: NCT03032848

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-26

Study Completion Date

2016-12-26

Brief Summary

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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

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Conditions

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Vaginitis Atropic Pelvic Organ Prolapse Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Conjugated Estrogen Group

use of 1 gram per day

Group Type ACTIVE_COMPARATOR

Promestriene

Intervention Type DRUG

use of 1 gram per day

Estriol

Intervention Type DRUG

use of 1 gram per day

Vaginal Moisturizer - Cream

Intervention Type DRUG

use of 1 gram per day

Promestriene Group

use of 1 gram per day

Group Type ACTIVE_COMPARATOR

Conjugated Estrogen

Intervention Type DRUG

use of 1 gram per day

Estriol

Intervention Type DRUG

use of 1 gram per day

Vaginal Moisturizer - Cream

Intervention Type DRUG

use of 1 gram per day

Estriol Group

use of 1 gram per day

Group Type ACTIVE_COMPARATOR

Conjugated Estrogen

Intervention Type DRUG

use of 1 gram per day

Promestriene

Intervention Type DRUG

use of 1 gram per day

Vaginal Moisturizer - Cream

Intervention Type DRUG

use of 1 gram per day

Vaginal Moisturizer Cream

use of 1 gram per day

Group Type PLACEBO_COMPARATOR

Conjugated Estrogen

Intervention Type DRUG

use of 1 gram per day

Promestriene

Intervention Type DRUG

use of 1 gram per day

Estriol

Intervention Type DRUG

use of 1 gram per day

Interventions

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Conjugated Estrogen

use of 1 gram per day

Intervention Type DRUG

Promestriene

use of 1 gram per day

Intervention Type DRUG

Estriol

use of 1 gram per day

Intervention Type DRUG

Vaginal Moisturizer - Cream

use of 1 gram per day

Intervention Type DRUG

Other Intervention Names

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Premarin Colpotrofine Stelle Vagidrat

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Paraná

OTHER

Sponsor Role lead

Responsible Party

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Elisa Chicareli Pinhat

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.

Reference Type RESULT
PMID: 23985562 (View on PubMed)

Taithongchai A, Johnson EE, Ismail SI, Barron-Millar E, Kernohan A, Thakar R. Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women. Cochrane Database Syst Rev. 2023 Jul 11;7(7):CD014592. doi: 10.1002/14651858.CD014592.pub2.

Reference Type DERIVED
PMID: 37431855 (View on PubMed)

Other Identifiers

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475.622

Identifier Type: REGISTRY

Identifier Source: secondary_id

23286013.7.0000.0096

Identifier Type: -

Identifier Source: org_study_id

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