Vaginal Creams to Reduce Vaginal Erosion in Pessary Users

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Atrophy of Vagina, Vaginal Ulceration, Vaginitis

In brief

To compare the use of Estrace ® vaginal cream against a placebo vaginal cream in reducing symptomatic vaginal discharge and vaginal erosion in patients who are using the Gellhorn or Ring with support pessaries.

Key facts

Study ID

NCT02316249

Run by

Northwell Health

People needed

0

Starts

2015-04-01

Expected to finish

2015-08-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Age >/= 18 years
• Female gender
• >/= Stage II pelvic organ prolapse
• Clinical diagnosis of pelvic organ prolapse and desiring non-surgical management with pessary
• Ability to provide informed consent and complete all study requirements

You may not qualify if…

• Life expectancy < 12 months
• Current pregnancy
• Patients will undergo a urine pregnancy test
• Already using vaginal estrogen
• Limited manual dexterity
• History of vaginal erosion with prior pessary use
• All patients with a past or present diagnosis of Breast cancer
• Patients with any pathology of the female reproductive organs
• Patients with undiagnosed abnormal genital bleeding
• Patients with known or suspected estrogen-dependent neoplasia
• Active deep vein thrombosis, pulmonary embolism or history of these conditions
• Active or recent (within last year) arterial thromboembolic disease
• Patients with liver dysfunction or disease
• Patients with known hypersensitivity to Estrace's ingredients

Where it is running

• Division of Urogynecology North Shore-LIJ School of Medicine — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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