Vaginal Creams to Reduce Vaginal Erosion in Pessary Users

• Status: Withdrawn
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwell Health
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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