drugset / Trial / NCT01648751
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
Terminated
21 enrolled
Pamela Moalli
American Urogynecologic Society · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institutes of Health (NIH) · collabPfizer · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.
Timeline
- Start
- 2012-05
- Primary completion
- 2023-03-02
- Completion
- 2023-03-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 1 g | Other |