Vaginal Creams to Reduce Vaginal Erosion in Pessary Users

NCT02316249 | Withdrawn Phase 2 DMC

• 1 other identifier: NSHS-P001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrophy of Vagina; Vaginal Ulceration; Vaginitis

Keywords

pelvic organ prolapse; Atrophy of Vagina; Gellhorn pessary; Ring with support pessary; Estrace cream; vaginitis with pessary; vaginal ulceration with pessary; vaginal erosion with pessary; pessary complications; vaginal bleeding with pessary

Outcome Measures

Primary Outcomes (1)

• Vaginal erosion

  To assess erosion/ulceration of vaginal tissue in patients using a Ring with support or Gellhorn Pessary for treatment of \>/= Stage II Pelvic Organ Prolapse

  6 months

Secondary Outcomes (3)

• Reason for Discontinuation of pessary based on style of pessary

  6 months

• Patient satisfaction with Pessary (Pelvic Floor Distress Inventory (PFDI)

  6 months

• vaginal discharge/vaginitis

  6 months

Study Arms (2)

Gellhorn Pessary

ACTIVE COMPARATOR

Patients who are fitted with a Gellhorn pessary for reduction of pelvic organ prolapse. Patients will then be randomized based on pessary to either Estradiol vaginal cream or Placebo vaginal cream. Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.

Drug: Estradiol; Other: placebo

Ring with Support Pessary

ACTIVE COMPARATOR

Patients who are fitted with a Ring with Support Pessary for reduction of pelvic organ prolapse. Patients will then be randomized based on pessary to either Estradiol vaginal cream or Placebo vaginal cream. Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.

Drug: Estradiol; Other: placebo

Interventions

Estradiol DRUG

Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.

Also known as: Estrace

Gellhorn Pessary; Ring with Support Pessary

placebo OTHER

Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.

Also known as: A hormone free base for vaginal creams

Gellhorn Pessary; Ring with Support Pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Division of Urogynecology North Shore-LIJ School of Medicine

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Vaginitis; Pelvic Organ Prolapse

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Lawrence Lind, MD

  Hofstra North Shore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 12, 2014
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)