Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

• Status: Active, not recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Pfizer; University of Alabama at Birmingham; Women and Infants Hospital of Rhode Island
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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