The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preoperative Oestrogen in Postmenopausal Women With Pelvic Organ Prolapse

NCT03779633

Pelvic Organ Prolapse

COMPLETED PHASE4

Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients

NCT03032848

Vaginitis Atropic Pelvic Organ Prolapse Endometrial Hyperplasia

COMPLETED PHASE4

Vaginal Estrogen With Pessary Treatment

NCT01843166

Vaginal Infection Urinary Tract Infection Quality of Life

COMPLETED NA

Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

NCT07030426

Pelvic Organ Prolapse (POP)

NOT_YET_RECRUITING PHASE3

Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

NCT03493126

Vaginal Atrophy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Organ Prolapse Vaginal Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Premarin cream 0.5gm

Application of 0.5gm of vaginal estrogen cream nightly until surgery.

Group Type ACTIVE_COMPARATOR

Vaginal conjugated estrogen cream 0.5gm

Intervention Type DRUG

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

Premarin cream 1.0gm

Application of 1.0gm of vaginal estrogen cream nightly until surgery.

Group Type ACTIVE_COMPARATOR

Vaginal conjugated estrogen cream 1.0gm

Intervention Type DRUG

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

No intervention

Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaginal conjugated estrogen cream 0.5gm

Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.

Intervention Type DRUG

Vaginal conjugated estrogen cream 1.0gm

Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Premarin Premarin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women aged 45 years or older
* Postmenopausal (\>55 if natural menopause)
* Clinical atrophic vaginitis (at least mild atrophy)
* Pelvic organ prolapse(at least stage 2 or greater)
* Posthysterectomy
* Surgery date between 2-12 weeks after recruitment

Exclusion Criteria

* Uterus present
* Well-estrogenized appearing vagina
* Known or suspected history of breast carcinoma
* Hormone-dependent tumor
* Genital bleeding of unknown cause
* Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
* Vaginal infection requiring treatment
* Allergy to estrogen or its constituents
* Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
* Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
* Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No