Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor (PET)

September 18, 2014 updated by: David Rahn, MD, University of Texas Southwestern Medical Center
This is a study to determine how vaginal estrogen cream given for several weeks before pelvic reconstructive therapy will effect elastic fiber assembly in the muscularis layer of the vaginal wall. Postmenopausal women with at least Stage 2 pelvic organ prolapse will receive either estrogen vaginal cream or placebo cream 6-8 weeks prior to reconstructive surgery. At time of surgery, full thickness biopsies will be obtained from a standardized location at the top of vagina. The investigators will measure the thickness of the vaginal muscularis, elastic fiber number and morphology, and analyze if elastic fiber synthesis or degradation is affected by estrogen therapy. The results will provide important data to support a larger clinical trial to determine if preoperative and maintenance estrogen therapy alter long-term success rates of pelvic reconstructive surgery for pelvic organ prolapse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women, still with uterus, planning total hysterectomy as part of surgical repair for pelvic organ prolapse
  • Symptomatic anterior and/or apical vaginal prolapse greater than or equal to Stage 2 (i.e., bulge extends to at least 1 cm of the hymen or beyond)
  • Women between 1 and 10 years after menopause. Menopause is defined as one year of amenorrhea or surgical ovariectomy.
  • Age 40-70 years old
  • No estrogen replacement therapy in the last 1 month
  • Physically capable of daily application of vaginal cream

Exclusion Criteria:

  • BMI >35
  • Prior surgical repair of prolapse involving the vaginal cuff.
  • Prior total hysterectomy
  • Premenopausal or postmenopausal >10 years
  • Prior steroid hormone replacement therapy of duration >1 month (oral or vaginal estrogen, testosterone or corticosteroids)
  • History of connective tissue disease (Ehlers-Danlos, Marfan, etc)
  • History of vaginal radiation
  • Contraindications for estrogen replacement therapy (current, or history of, spontaneous deep vein thrombosis, stroke, coronary artery disease, breast or endometrial cancer)
  • Concurrent use of steroid cream for treatment of Lichen sclerosis
  • Recent history (within last month) of vaginal infection or vaginitis
  • Current tobacco use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Premarin
Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Drug: Premarin
Other Names:
  • Conjugated equine estrogen
PLACEBO_COMPARATOR: Placebo
Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.
Other: Placebo
Other Names:
  • Placebo cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaginal Wall Composition: Epithelium (Intention to Treat)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess vaginal wall histology - thicknesses of epithelium
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Composition: Epithelium (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess vaginal wall histology - thicknesses of epithelium
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Composition: Muscularis (Intention to Treat)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess vaginal wall histology - thicknesses of muscularis
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Composition: Muscularis (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess vaginal wall histology - thicknesses of muscularis
Time of surgery, i.e. after 6-8 weeks of intervention
hCOL1A1, Per-Protocol
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
Total Collagen Content in Vaginal Muscularis, (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess hydroxy-proline assays as index of amount of collagen
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Degradative Activity, Muscularis, MMP-9
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess zymograms for total matrix metalloprotease (MMP) 9 activity
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Composition: Lamina Propria (Intention to Treat)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess vaginal wall histology - thickness of lamina propria.
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Composition: Lamina Propria (Per-Protocol)
Time Frame: Time of surgery, i.e. 6-8 weeks of intervention
Will assess vaginal wall histology - thickness of lamina propria
Time of surgery, i.e. 6-8 weeks of intervention
hCOL3, (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
Lysyl Oxidase (LOX) (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
LOXL1 (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
Tropoelastin (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
TGFB1 (Per-Protocol)
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Data represent ratio of total mRNA relative to postmenopausal external control.
Time of surgery, i.e. after 6-8 weeks of intervention
Vaginal Wall Degradative Activity, Mucosa, MMP-9
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Will assess zymograms for total matrix metalloprotease (MMP) 9 activity
Time of surgery, i.e. after 6-8 weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Estrone Levels, Baseline
Time Frame: Baseline
Baseline
Serum Estrone Levels, Surgery
Time Frame: Time of surgery
Time of surgery
Serum Estradiol Levels, Baseline
Time Frame: Baseline
Baseline
Serum Estradiol Levels, Surgery
Time Frame: Time of surgery
Time of surgery
Estimated Blood Loss
Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention
Intraoperative estimated blood loss
Time of surgery, i.e. after 6-8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Urogynecologic Society Foundation Astellas Research Award

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU-042011-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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