Hormonal Status on Blood Flow and Tissue in Pelvic Organ Prolapse
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|ClinicalTrials.gov Identifier: NCT01886794|
Recruitment Status : Recruiting
First Posted : June 26, 2013
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Floor Disorders||Drug: Postmenopausal, topical vaginal cream Drug: Placebo Comparator: Postmenopausal, topical placebo cream||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2021|
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.
Drug: Postmenopausal, topical vaginal 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.
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.
Drug: Placebo Comparator: Postmenopausal, topical placebo cream
Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
- Vaginal epithelial thickness [ Time Frame: 1-month perioperative study ]Measure of vaginal epithelial thickness obtained by optical coherence tomography
- Histologic assessment of excised tissue [ Time Frame: 1-month perioperative study ]Evaluation of histology from surgery for collagen and elastin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886794
|Contact: Lauren Dawson, BSfirstname.lastname@example.org|
|United States, Texas|
|UTMB Speciality Care Center at Victory Lakes||Recruiting|
|League City, Texas, United States, 77573|
|Contact: Tristi Muir, MD 409-747-6625 email@example.com|
|Principal Investigator: Kathleen L Vincent, MD|
|Sub-Investigator: Erin Conroy, MD|
|Principal Investigator:||Kathleen Vincent, MD||UTMB Galveston|