Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

Conditions:Cervical Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Age Range:48 - Any
Start Date:December 2016
End Date:December 2020
Contact:David D Rahn, MD

Use our guide to learn which trials are right for you!

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

This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens,
0.625mg/1g cream) vs. placebo in postmenopausal women (n=222 total) with symptomatic prolapse
beyond the hymen planning transvaginal native tissue repairs. Medication will be started 6-8
weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is
complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen
therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ
support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence,
sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal
wound healing. Finally, (iii) the investigators will determine the potential mechanisms by
which local estrogen treatment alters pelvic organ support by examining full-thickness
vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and
smooth muscle synthesis and degradative changes. The investigators expect this will highlight
other novel targets for future therapies in prolapse repair and prevention.

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
We found this trial at
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Birmingham, AL
Click here to add this to my saved trials
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: David D Rahn, MD
Phone: 214-648-6430
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
Dallas, TX
Click here to add this to my saved trials
101 Dudley St
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
Providence, RI
Click here to add this to my saved trials