Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor (PET)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Texas Southwestern Medical Center
Collaborator:
American Urogynecologic Society Foundation Astellas Research Award
Information provided by (Responsible Party):
David Rahn, MD, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01778985
First received: January 23, 2013
Last updated: March 21, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pelvic Organ Prolapse Menopause |
Drug: Premarin Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor |
Resource links provided by NLM:
Further study details as provided by University of Texas Southwestern Medical Center:
Primary Outcome Measures:
- Vaginal wall composition [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ] [ Designated as safety issue: No ]Will assess vaginal wall histology - relative thicknesses of epithelium, lamina propria, and muscularis; description of elastic fiber morphology
- Vaginal wall elastic fiber and collagen: synthesis [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ] [ Designated as safety issue: No ]Will assess mRNA levels of collagen I and III, lysyl oxidase (LOX), LOXL1, tropoelastin, and TGF beta
- Vaginal wall collagen: synthesis [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ] [ Designated as safety issue: No ]Will assess hydroxy-proline assays as index of amount of collagen
- Vaginal wall elastic fiber and collagen: degradative activity [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ] [ Designated as safety issue: No ]Will assess zymograms for matrix metalloprotease (MMP) 2 and 9 activity
- Vaginal wall elastic fiber: synthesis [ Time Frame: Time of surgery, i.e. after 6-8 weeks of intervention ] [ Designated as safety issue: No ]Will assess western blots for assessment of amounts of lysyl oxidase and fibulin-5 proteins
Secondary Outcome Measures:
- Serum and vaginal mucosa estrone and estradiol levels [ Time Frame: Before and after 6-8 weeks of intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Placebo cream
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 (Ehler 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778985
Locations
| United States, Texas | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Urogynecologic Society Foundation Astellas Research Award
More Information
No publications provided
| Responsible Party: | David Rahn, MD, Assistant Professor, Dept. of Obstetrics & Gynecology, University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT01778985 History of Changes |
| Other Study ID Numbers: | STU-042011-101 |
| Study First Received: | January 23, 2013 |
| Last Updated: | March 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Pelvic organ prolapse Menopause Estrogen Premarin |
Additional relevant MeSH terms:
|
Prolapse 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 May 22, 2013