Effects of Ospemifene on Pelvic Vascularity and Blood Flow

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

Sponsors

Lead Sponsor: University of Oklahoma

Source University of Oklahoma
Brief Summary

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].

Overall Status Withdrawn
Start Date January 2014
Completion Date August 2014
Primary Completion Date August 2014
Study Type Observational
Primary Outcome
Measure Time Frame
Doppler Flow Analysis 3 months post-treatment
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Abbas Shobeiri, MD Principal Investigator University of Oklahoma
Verification Date

December 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Arm Group

Label: Osphena

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

Acronym Osphena
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov