Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse
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ClinicalTrials.gov Identifier: NCT01648751 |
Recruitment Status :
Recruiting
First Posted : July 24, 2012
Last Update Posted : February 4, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pelvic Organ Prolapse | Drug: Vaginal estrogen Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Vaginal estrogen
Patients in the experimental group will receive vaginal estrogen cream
|
Drug: Vaginal estrogen
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Other Name: Premarin vaginal cream |
Placebo Comparator: Placebo cream
Patients in the comparison group will receive placebo vaginal cream
|
Drug: Placebo
1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
Other Name: Placebo cream |
- Global impression of improvement in prolapse symptoms, using the PGI-I [ Time Frame: 6 months ]To determine the impact of vaginally delivered estrogen on global impression of improvement in women with symptomatic mild pelvic organ prolapse who are undergoing pelvic floor physical therapy
- Pelvic floor symptoms, using the PFDI-20 [ Time Frame: 6 months ]
- Quality of life, using the PFIQ-7 [ Time Frame: 6 months ]
- Sexual function, using the PISQ-12 [ Time Frame: 6 months ]
- Pelvic organ prolapse stage, using the POP-Q exam [ Time Frame: 6 months ]
- Collagenase activity [ Time Frame: 6 months ]Vaginal swabs collected from the posterior fornix will be used for biochemical analysis

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women in good health aged 40-80
- Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:
Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
- Meets POP-Q criteria on exam for stage I, II, or III prolapse
- Interested in PFPT for management of POP
- Normal mammogram within 1 year of enrollment
Exclusion Criteria:
- Prior surgery for prolapse or incontinence
- Other prior interventions for prolapse (e.g. pessary, PFPT)
- Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
- Known liver dysfunction
- Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
- Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year
- BMI > 35 kg/m2
- Estrogen therapy (including birth control) in the previous year
- Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)
- Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)

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): NCT01648751
Contact: Laura C Skoczylas, MD, MS | 323-857-2238 | lauraskoczylas@gmail.com | |
Contact: Pamela Moalli, MD, PhD | moalpa@mail.magee.edu |
United States, Pennsylvania | |
Magee-Womens Hospital, University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Lori Geraci, BS 412-641-2634 | |
Sub-Investigator: Laura C Skoczylas, MD, MS | |
Principal Investigator: Pamela Moalli, MD, PhD |
Study Director: | Laura C Skoczylas, MD, MS | University of Pittsburgh | |
Principal Investigator: | Pamela Moalli, MD, PhD | University of Pittsburgh |
Responsible Party: | Pamela Moalli, Associate Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01648751 |
Other Study ID Numbers: |
PRO09090064 R01HD061811 ( U.S. NIH Grant/Contract ) |
First Posted: | July 24, 2012 Key Record Dates |
Last Update Posted: | February 4, 2022 |
Last Verified: | February 2022 |
Pelvic organ prolapse Pelvic floor physical therapy Vaginal estrogen Placebo |
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |