Effect of Preoperative Estrogen Treatment on Connective Tissues of the Pelvic Floor

NCT ID: NCT01778985

Last Updated: 2014-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-04-30

Brief Summary

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.

Conditions

Pelvic Organ Prolapse; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Premarin

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Premarin

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Conjugated equine estrogen; Placebo cream

Eligibility 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 (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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Urogynecologic Society Foundation Astellas Research Award

UNKNOWN

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Rahn, MD

Assistant Professor, Dept. of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3728-36. doi: 10.1210/jc.2014-1216. Epub 2014 Jun 20.

Reference Type: DERIVED

PMID: 24947034 (View on PubMed)

Other Identifiers

STU-042011-101

Identifier Type: -

Identifier Source: org_study_id