NCT02010580

Withdrawn

Effects of Ospemifene on Pelvic Vascularity and Blood Flow

University of Oklahoma Source

University of Oklahoma

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

3555

Study Type

observational

Actual enrollment (reported)

0

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

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 \[8-11\].

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: withdrawn
Actual enrollment (reported): 0 participants
Study completion date: August 2014
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 9, 2013
Actual (reported)
First Posted
December 12, 2013
Actual (reported)
Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)
Study Completion
August 2014
Actual (reported)

Last Updated: December 3, 2014
Status Verified: December 2014
Last Update Submitted: December 2, 2014

Conditions

Menopause

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

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.

You may qualify if:

Female gender

Sponsors & Collaborators

University of Oklahoma
Otherlead

Study Officials

Abbas Shobeiri, MD
University of Oklahoma
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

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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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

Last Updated

December 3, 2014

Record last verified: 2014-12

Source record

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Registry identifier: NCT02010580
Data provider: ClinicalTrials.gov
Source updated: 2014-12-03
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Osphena

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record