Effects of Ospemifene on Pelvic Vascularity and Blood Flow

NCT ID: NCT02010580

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-08-31

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].

Conditions

Menopause

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbas Shobeiri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Other Identifiers

3555

Identifier Type: -

Identifier Source: org_study_id