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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT00803335
First received: December 4, 2008
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Pelvic Organ Prolapse
Vaginal Atrophy
Drug: Vaginal conjugated estrogen cream 0.5gm
Drug: Vaginal conjugated estrogen cream 1.0gm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: December 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Premarin cream 0.5gm
Women in this arm will apply 0.5gm of premarin vaginal cream nightly until surgery.
Drug: Vaginal conjugated estrogen cream 0.5gm
Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
Other Name: Premarin
Experimental: Premarin cream 1.0gm
Women will apply 1.0gm of premarin vaginal cream nightly until surgery.
Drug: Vaginal conjugated estrogen cream 1.0gm
Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
Other Name: Premarin
No Intervention: No intervention
Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803335

Locations
United States, Ohio
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Christine M Vaccaro, DO Good Samaritan Hospital
  More Information

No publications provided

Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT00803335     History of Changes
Other Study ID Numbers: 08135-08-076
Study First Received: December 4, 2008
Last Updated: February 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
pelvic organ prolapse
vaginal atrophy
atrophic vaginitis
postmenopausal
posthysterectomy
vaginal health
vaginal cytology
vaginal maturity index
vaginal histology
quality of life questionnaires

Additional relevant MeSH terms:
Prolapse
Atrophy
Pelvic Organ Prolapse
Pathological Conditions, Anatomical
Estrogens, Conjugated (USP)
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014