Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

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NCT02431897

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Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
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Contact
1-800-718-1021
[email protected]
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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
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
  1. Birmingham, Alabama
  2. Providence, Rhode Island
  3. 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
  • Pelvic Organ Prolapse
  • Urogenital Prolapse
  • Vaginal Vault Prolapse
  • Cystocele
  • Uterine Prolapse
  • Vaginal Prolapse
  • Pelvic Floor Disorders
Intervention  ICMJE
  • Drug: Conjugated Estrogens Cream
    0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
    Other Name: Premarin Vaginal Cream
  • Drug: Placebo Cream
    1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
Study Arms  ICMJE
  • Experimental: Estrogen Cream
    Intervention: Drug: Conjugated Estrogens Cream
  • Placebo Comparator: Placebo Cream
    Intervention: Drug: Placebo Cream
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
 (submitted: June 9, 2020)		206
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2015)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
  • University of Alabama at Birmingham
  • Women and Infants Hospital of Rhode Island
  • Pfizer
Investigators  ICMJE
Principal Investigator:David D Rahn, MDUniversity of Texas Southwestern Medical Center
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