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OpenTrials
Completed

NCT Number: NCT00803335

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Atrophic Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urogenital Diseases Vaginal Atrophy Vaginal Diseases Vaginitis

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Trihealth (Good Samaritan Hospital, Bethesda North Hospital)

Cincinnati, Ohio, 45220, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vaginal conjugated estrogen cream 0.5gm

Drug

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

Other names: Premarin

Vaginal conjugated estrogen cream 1.0gm

Drug

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

Other names: Premarin

Primary outcomes

  1. Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.

    Time frame: baseline and 2-12 weeks after treatment (at time of surgery)

Secondary outcomes

  1. Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.

    Time frame: baseline and 2-12 weeks after treatment (at time of surgery)

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2008
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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