Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

Completed · Phase 4 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse, Pelvic Floor Disorders

In brief

This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.

Key facts

Study ID

NCT02431897

Run by

University of Texas Southwestern Medical Center

People needed

206

Starts

2016-12-01

Expected to finish

2023-05-17

Last updated by the study team

2023-09-06

Who can join

Age: 48 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal: no menses for >1 year
• Minimum age: 48 years
• Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
• No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
• Medically fit for elective surgery
• Physically able to apply/insert the study drug
• Available for clinic follow-up for minimum 1yr

You may not qualify if…

• Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
• BMI >35 kg/m2
• Recent history (within last month) of vaginal infection or vaginitis
• Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
• History of connective tissue disease
• Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
• History of vaginal irradiation
• Allergy to Premarin or its constituents
• Prior apical repair or use of mesh for prolapse repair
• Current tobacco use

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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