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Effects of Ospemifene on Pelvic Vascularity and Blood Flow

NCT02010580 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2014-12-03

No results posted yet for this study

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 \[8-11\].

Conditions

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Abbas Shobeiri, MD · University of Oklahoma

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010580 on ClinicalTrials.gov