Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
TriHealth Inc. Hatton Institute for Research and Education |
---|---|
Information provided by: | TriHealth Inc. |
ClinicalTrials.gov Identifier: | NCT00803335 |
The purpose of this study is to find out how long it takes teh vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.
Condition | Intervention |
---|---|
Pelvic Organ Prolapse Vaginal Atrophy |
Drug: conjugated equine estrogen cream |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial |
Estimated Enrollment: | 60 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
These women will use 0.5gms of Premarin vaginal cream nightly until scheduled surgery date.
|
Drug: conjugated equine estrogen cream
Premarin vaginal cream 0.5gms, applied to vagina nightly
|
2: Active Comparator
These women will use 1.0gm of Premarin vaginal cream nightly until scheduled surgery date.
|
Drug: conjugated equine estrogen cream
Premarin Vaginal Cream 1.0gm, applied to vagina nightly
|
3: No Intervention
No cream or other placebo moisturizer will be given.
|
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine M Vaccaro, D.O. | 513-872-4171 | Christine_Vaccaro@trihealth.com |
Contact: Angie Fellner, M.A. | 513-872-2330 | Angie_Fellner@trihealth.com |
United States, Ohio | |
Trihealth (Good Samaritan Hospital, Bethesda North Hospital) | Recruiting |
Cincinnati, Ohio, United States, 45220 | |
Contact: Christine M Vaccaro, D.O. 513-872-4171 Christine_Vaccaro@trihealth.com | |
Contact: Rachel Pauls, M.D. 513-872-4171 Rachel_Pauls@trihealth.com | |
Principal Investigator: Christine M Vaccaro, D.O. | |
Sub-Investigator: Rachel Pauls, M.D. | |
Sub-Investigator: George Mutema, M.D. |
Responsible Party: | Advanced Urogynecology ( Christine Vaccaro, D.O. ) |
Study ID Numbers: | 08135-08-076 |
Study First Received: | December 4, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00803335 |
Health Authority: | United States: Institutional Review Board |
pelvic organ prolapse vaginal atrophy atrophic vaginitis postmenopausal posthysterectomy |
vaginal health vaginal cytology vaginal maturity index vaginal histology quality of life questionnaires |
Pathological Conditions, Anatomical Estrogens, Conjugated (USP) Digestive System Diseases Gastrointestinal Diseases Vaginitis Quality of Life |
Atrophy Intestinal Diseases Rectal Diseases Prolapse Rectal Prolapse |
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |