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

December 4, 2008
February 17, 2014
December 2008
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00803335 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse
The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pelvic Organ Prolapse
  • Vaginal Atrophy
  • Drug: Vaginal conjugated estrogen cream 0.5gm
    Women in this arm will apply 0.5gm vaginal estrogen cream nightly until surgery.
    Other Name: Premarin
  • Drug: Vaginal conjugated estrogen cream 1.0gm
    Women in this arm will apply 1.0gm vaginal estrogen cream nightly until surgery.
    Other Name: Premarin
  • Experimental: Premarin cream 0.5gm
    Women in this arm will apply 0.5gm of premarin vaginal cream nightly until surgery.
    Intervention: Drug: Vaginal conjugated estrogen cream 0.5gm
  • Experimental: Premarin cream 1.0gm
    Women will apply 1.0gm of premarin vaginal cream nightly until surgery.
    Intervention: Drug: Vaginal conjugated estrogen cream 1.0gm
  • No Intervention: No intervention
    Women in this arm will not apply any cream or moisturizers to the vagina until surgery, ie no intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00803335
08135-08-076
No
TriHealth Inc.
TriHealth Inc.
Not Provided
Principal Investigator: Christine M Vaccaro, DO Good Samaritan Hospital
TriHealth Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP