Patient Adherence to Premarin Versus Vagifem Therapy After Female Pelvic Reconstructive Surgery

NCT02860897 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 08-15-39
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: To evaluate patient adherence to cream versus tablet based local estrogen therapy by randomizing treatment modalities to determine differences in adherence to either form. HYPOTHESIS: There is no difference in adherence to cream versus tablet based local estrogen therapy when prescribed as a 6 week course of postoperative therapy after female pelvic reconstructive surgery.

Conditions

Estrogen; Menopause; Pelvic Floor Disorders; Surgery

Outcome Measures

Primary Outcomes (1)

• Time in days to discontinuation of vagifem tablet or premarin cream.

  Days upon which patients stopped using vagifem tablets or premarin cream

  6 weeks

Secondary Outcomes (2)

• Pelvic floor disease inventory-20

  preoperatively, 2 weeks, 6 weeks.

• Postoperative complications

  6 weeks

Study Arms (2)

Vaginal estrogen cream

EXPERIMENTAL

Drug: Premarin

Vaginal estrogen tablet

EXPERIMENTAL

Drug: Vagifem

Interventions

Premarin DRUG

Vaginal estrogen cream

Vaginal estrogen cream

Vagifem DRUG

Vaginal estrogen tablet

Vaginal estrogen tablet

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent female pelvic reconstructive surgery at University Hospitals Case Medical Center and were given postoperative local estrogen therapy.
• Patients who consented to the study.
• Postmenopausal

You may not qualify if:

• Patients who were not given a prescription for postoperative lower estrogen therapy despite undergoing surgery.
• Patients with contraindications to vaginal estrogen.
• Any obliterative procedures. Patients who are unable to participate in informed consent. Patients younger than 18. Non English speaking patients

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Estrogens, Conjugated (USP); Estradiol

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 9, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)