MenopauseOsphenaNCT02010580
Effects of Ospemifene on Pelvic Vascularity and Blood Flow
An observational study of Menopause, run by University of Oklahoma.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopause
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
About this study
Official title: The Effects of Vaginal Ospemifene on Pelvic Organ Vascularity and Blood Flow in Postmenopausal Women
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].
- Conditions
- Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Never received necessary funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abbas Shobeiri, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010580
- Sponsor's protocol ID
- 3555
- Acronym
- Osphena
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vaginal Ospemifene on Pelvic Organ Vascularity and Blood Flow in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02010580
- Acronym / sponsor ID
- Osphena / 3555
- Conditions
- Menopause
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never received necessary funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Doppler Flow Analysis
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas Shobeiri, MD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler Flow Analysis (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.