Effects of Ospemifene on Pelvic Vascularity and Blood Flow

Menopause Clinical Trial

— Osphena  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02010580
• Other study ID #: 3555
• Status: Withdrawn
• Phase: N/A
• First received: December 9, 2013
• Last updated: December 2, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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].

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menopause

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doppler Flow Analysis	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.	3 months post-treatment	No