- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01886794
Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
March 8, 2024 updated by: The University of Texas Medical Branch, Galveston
Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
Study Overview
Status
Terminated
Conditions
Detailed Description
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery.
At the time of surgery, we will obtain tissue for histologic and imaging analysis.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77550
- UTMB Galveston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 21 to 70 years of age
- Stage II or greater pelvic organ prolapse (POP)
- Individuals electing surgery to treat their POP
- Willing and able to comply with study procedures
- Willing and able to provide written informed consent
Exclusion Criteria:
- Contraindication for estrogen cream
- Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
- History of connective tissue disease
- Previous hysterectomy or pelvic organ prolapse surgery
- Known allergic reaction to any agent required by the protocol
- Use of hormone therapy in postmenopausal women in the last 90 days
- Pregnant or lactating females
- History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Postmenopausal, topical vaginal cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery.
These will include those women randomized to estrogen cream.
|
Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery.
This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
Other Names:
|
No Intervention: Pre-menopausal, no topical vaginal cream
Pre-menopausal, no topical vaginal cream.
These women will be examined at different stages in their menstrual cycle in order to compare characteristics of the cycle at high and lower estrogen timepoints.
|
|
Placebo Comparator: Postmenopausal, topical placebo cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery.
These will include those women randomized to placebo.
|
Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal epithelial thickness
Time Frame: 1-month perioperative study
|
Measure of vaginal epithelial thickness obtained by optical coherence tomography
|
1-month perioperative study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histologic assessment of excised tissue
Time Frame: 1-month perioperative study
|
Evaluation of histology from surgery for collagen and elastin
|
1-month perioperative study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kathleen Vincent, MD, UTMB Galveston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2013
Primary Completion (Actual)
December 11, 2023
Study Completion (Actual)
December 11, 2023
Study Registration Dates
First Submitted
June 14, 2013
First Submitted That Met QC Criteria
June 21, 2013
First Posted (Estimated)
June 26, 2013
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Pregnancy Complications
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Prolapse
- Pelvic Organ Prolapse
- Pelvic Floor Disorders
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
Other Study ID Numbers
- 13-114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Floor Disorders
-
University Hospitals of North Midlands NHS TrustActive, not recruitingPelvic Floor DysfunctionUnited Kingdom
-
Peking UniversityActive, not recruitingPelvic Floor DysfunctionChina
-
Columbia UniversityUniversity of Wisconsin, Madison; University of Calgary; University of Arkansas; The Methodist Hospital Research InstituteCompleted
-
Assiut UniversityWithdrawn
-
Peking Union Medical College HospitalThe First Affiliated Hospital with Nanjing Medical University; Peking University... and other collaboratorsRecruiting
-
Cathay General HospitalCompleted
-
Federal University of UberlandiaCompleted
-
Universitat Autonoma de BarcelonaCompleted
-
University of Sao PauloCompleted
-
Peking Union Medical College HospitalNot yet recruitingPelvic Floor Dysfunction
Clinical Trials on Postmenopausal, topical vaginal estrogen cream
-
University of LouisvilleCompletedMenopause | Atrophic Vaginitis | Recurrent Urinary Tract InfectionsUnited States
-
Meir Medical CenterCompletedVulvovaginal Atrophy | Dyspareunia Among Puerperal WomenIsrael
-
Pamela MoalliEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingPelvic Organ ProlapseUnited States
-
TriHealth Inc.CompletedPelvic Organ Prolapse | Vaginal AtrophyUnited States
-
The University of Texas Health Science Center,...TerminatedVaginosis, Bacterial | Vaginal Discharge | VaginosisUnited States
-
Medstar Health Research InstitutePfizerTerminatedMicroscopic HematuriaUnited States
-
Amazentis SAproDERM GmbHCompleted
-
Amazentis SAproDERM GmbHCompletedErythema | Skin Inflammation | Sun Damaged SkinGermany
-
Medical University of SilesiaCompletedCannabis | Myofascial Pain | Temporomandibular Disorder | ElectromyographyPoland
-
Memorial Sloan Kettering Cancer CenterIncyte Corporation; Hackensack Meridian HealthCompletedNon-sclerotic Cutaneous Chronic Graft-versus-host DiseaseUnited States