Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
NCT02431897
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse, Pelvic Floor Disorders
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
48 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Pelvic Organ Prolapse, Urogenital Prolapse, Vaginal Vault Prolapse, Cystocele, Uterine Prolapse, Vaginal Prolapse, Pelvic Floor DisordersInvestigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
NCT02431897
- Birmingham, Alabama
- Providence, Rhode Island
- Dallas, Texas
Female
48 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen | |||
| Official Title ICMJE | Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen | |||
| Brief 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. | |||
| Detailed Description | 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 >5 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Active, not recruiting | |||
| Actual Enrollment ICMJE | 206 | |||
| Original Estimated Enrollment ICMJE | 276 | |||
| Estimated Study Completion Date ICMJE | June 30, 2023 | |||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 48 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02431897 | |||
| Other Study ID Numbers ICMJE | STU 022015-117 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | David Rahn, MD, University of Texas Southwestern Medical Center | |||
| Study Sponsor ICMJE | University of Texas Southwestern Medical Center | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Texas Southwestern Medical Center | |||
| Verification Date | June 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||