Effects of Ospemifene on Pelvic Vascularity and Blood Flow (Osphena)

The Effects of Vaginal Ospemifene on Pelvic Organ Vascularity and Blood Flow in Postmenopausal Women

Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (Osphena, Shionogi, Florham, NJ) or placebo tablet. Placebo tablets will be identical in appearance and packaging will be identical for the two pills. The participants will be instructed to take one tablet in the morning with food for twelve weeks. Basic demographic information will be obtained on all participants. All women will undergo a pelvic examination, and questionnaires regarding pelvic floor dysfunction and sexual function before and three months after treatment. 3-D ultrasound with Doppler blood flow analysis will be performed before the patient is started on the treatment. 3 months after treatment, the 3-D ultrasound with Doppler blood flow analysis will be repeated. Four areas will be measured:

1. The urethra in exactly the same section at the same level with the same setups.
2. 3 and 9 O'clock position
3. 6 o'clock position
4. Clitoral blood flow Doppler blood flow will be visualized using the Doppler color mode of the ultrasound machine and will be applied for the assessment of the vascularity pattern. Additionally, we will record a film with the use of Color Doppler in a video file. The transducer will be immobilized at one selected section and record a ten seconds of film. This film will be further analyzed in special software called Pixel flux after the examination. Dr. Pawel Wieczorek and Dr. Magdalena Wozniak will read these deidentified video files in a randomized fashion based on their previous research experience with similar video interpretations of pelvic color Doppler imaging [8-11].

Study Overview

• Status: Withdrawn
• Conditions: Menopause

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

We estimate that we will need a total of 30 patients recruited to this study. Eligible subjects will be postmenopausal women who have undergone menopause and have had a hysterectomy.

Description

Inclusion Criteria:

• Female gender
• Available for reliable follow up
• Able to complete study assessment
• Mammogram within the last year
• Menopausal (at least 12 months since last spontaneous menstrual bleeding)

Exclusion Criteria:

• Age <18 years
• Dementia or inability to follow instructions
• Prior pelvic floor radiation
• History of uterine, ovarian, fallopian tube, breast, or colon cancer
• Current use or use within the last 6 months of estrogen (vaginal, oral, transdermal, compounded)
• Current use of alternative medicines including black cohosh, evening primrose, dong quai, or chasteberry
• Known prothrombotic mutations such as Factor V Leiden, prothrombin mutation, protein C or Protein S deficiency
• History of or current thrombophelbitis or venous thromboembolic disorders
• Currently using fluconazole or rifampin

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Osphena; Subjects will be randomized in a ratio of 1:1 to receive either 60 mg of ospemifene (Osphena, Shionogi, Florham, NJ) or placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doppler Flow Analysis	To prospectively evaluate, by three-dimensional (3-D) Doppler flow analysis, the hemodynamic vaginal blood flow variations between women receiving oral ospemifene versus women receiving placebo.	3 months post-treatment

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Abbas Shobeiri, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 3555