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Osphena: Effects of Ospemifene on Pelvic Vascularity and Blood Flow

Sponsor
University of Oklahoma (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02010580
Collaborator
(none)
0
Enrollment
7
Duration (Months)

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effects of Vaginal Ospemifene on Pelvic Organ Vascularity and Blood Flow in Postmenopausal Women
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Aug 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Doppler Flow Analysis [3 months post-treatment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT02010580
    Other Study ID Numbers:
    • 3555
    First Posted:
    Dec 12, 2013
    Last Update Posted:
    Dec 3, 2014
    Last Verified:
    Dec 1, 2014

    Study Results

    No Results Posted as of Dec 3, 2014