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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Nausea and vomiting

Granulation tissue

Dyspareunia

Vaginal itching

Trimalleolar fracture, closed

Constipation

Fractured hip

Stroke

Anaphylactic shock due to adverse food reaction

Sepsis

Infection MRSA

Carcinoma breast stage II

Pneumonia

Endometrial carcinoma

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,907,844 Total Patients Enrolled

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,593 Total Patients Enrolled

1 Trials studying Uterine Prolapse

63 Patients Enrolled for Uterine Prolapse

University of Alabama at BirminghamOTHER

1,580 Previous Clinical Trials

2,275,789 Total Patients Enrolled

1 Trials studying Uterine Prolapse

150 Patients Enrolled for Uterine Prolapse

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have Conjugated Estrogens Cream been explored in past research efforts?

"Initially tested in 1996 at National Institutes of Health Clinical Center, Conjugated Estrogens Cream has since been evaluated 249 times. Presently, 56 trials are underway with a significant concentration located in Birmingham, Alabama."

Answered by AI

Is there still availability for participants in this trial?

"As of the most recent update on November 29th 2021, this study is not enrolling patients. It was first posted four years ago on December 1st 2016. However, if you are looking for other medical trials, there are presently 1125 clinical studies recruiting participants with cystocele and 56 actively seeking volunteers for Conjugated Estrogen Cream research."

Answered by AI

What medical ailments is Conjugated Estrogens Cream typically prescribed to address?

"Conjugated Estrogens Cream is prescribed to treat organic ailments, such as advanced androgen dependent prostate cancer, amenorrhea in the preceding 6 months, or hypoestrogenism."

Answered by AI

To what extent is the participant pool expanding for this research?

"This clinical trial is not currently accepting new participants. It was first published in December 2016, and the most recent update from November 2021 confirms that it has since concluded. If you are searching for other studies related to cystocele there are 1125 active trials; conversely, if you require conjugated estrogens cream then 56 separate investigations may be of interest."

Answered by AI

Has the FDA sanctioned Conjugated Estrogens Cream for use?

"Conjugated Estrogens Cream has demonstrated a high level of safety, thus receiving a score of 3. This is due to this treatment already being approved and entering Phase 4 clinical trials."

Answered by AI

Recent research and studies

Female Pelvic Medicine & Reconstructive SurgeryJournal

Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo with Transvaginal Native Tissue Apical Prolapse Repair (investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen: IMPROVE)

Rahn, David D., Holly E. Richter, Vivian W. Sung, Wilma I. Larsen, and Linda S. Hynan. 2021. “Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo with Transvaginal Native Tissue Apical Prolapse Repair (investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen: IMPROVE)”. Female Pelvic Medicine & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spv.0000000000000899.

clinicaltrials.govStudy

Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen

David Rahn, MD 2016. "Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02431897.