Menopause Clinical Trial
Official title:
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].
n/a
Observational Model: Cohort, Time Perspective: Prospective
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