Effects of Ospemifene on Pelvic Vascularity and Blood Flow | NCT02010580

Studies
Effects of Ospemifene on Pelvic Vascularity and Blood Flow

NCT02010580

Sponsor

University of Oklahoma

Status

Withdrawn

Last Update Posted

Dec 3, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Menopause

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never received necessary funding.

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Dec 9, 2013

First Submission Date that Met QC Criteria

Dec 9, 2013

First Posted Date

Dec 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2014

Last Update Posted Date

Dec 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

The urethra in exactly the same section at the same level with the same setups.
3 and 9 O'clock position
6 o'clock position
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].

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

We estimate that we will need a total of 30 patients recruited to this study. Eligible subjects will be postmenopausal women who have undergone menopause and have had a hysterectomy.

Sampling Method

Probability Sample