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Conjugated Estrogens Cream for Uterine Prolapse (IMPROVE Trial)

Phase 4
Waitlist Available
Led By David D Rahn, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

IMPROVE Trial Summary

This trial is testing whether using estrogen cream before and after surgery to repair pelvic organ prolapse will improve success rates and minimize recurrence.

Eligible Conditions
  • Uterine Prolapse
  • Pelvic Floor Dysfunction
  • Cystocele
  • Pelvic Organ Prolapse
  • Urogenital Prolapse
  • Vaginal Vault Prolapse
  • Vaginal Prolapse

IMPROVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
Secondary outcome measures
Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire
Generic Quality of Life as Measured by SF-12 Questionnaire
+4 more

Side effects data

From 2023 Phase 4 trial • 206 Patients • NCT02431897
18%
Urinary tract infection
10%
Yeast infection
7%
Nausea and vomiting
7%
Granulation tissue
6%
Dyspareunia
6%
Vaginal itching
3%
Trimalleolar fracture, closed
3%
Constipation
1%
Fractured hip
1%
Stroke
1%
Anaphylactic shock due to adverse food reaction
1%
Sepsis
1%
Infection MRSA
1%
Carcinoma breast stage II
1%
Pneumonia
1%
Endometrial carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Cream
Estrogen Cream

IMPROVE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Estrogen CreamExperimental Treatment1 Intervention
Conjugated Estrogens cream
Group II: Placebo CreamPlacebo Group1 Intervention
Placebo cream
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Conjugated Estrogens Cream
2019
Completed Phase 4
~240

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,587 Previous Clinical Trials
14,637,656 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,057 Previous Clinical Trials
1,054,895 Total Patients Enrolled
1 Trials studying Uterine Prolapse
63 Patients Enrolled for Uterine Prolapse
University of Alabama at BirminghamOTHER
1,598 Previous Clinical Trials
2,286,556 Total Patients Enrolled
1 Trials studying Uterine Prolapse
150 Patients Enrolled for Uterine Prolapse
~24 spots leftby Jun 2025
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