Office HysteroscopyPhase 4NCT03683914
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients
A Phase 4 study testing Dinoprostone 3Mg Vaginal Tablet in people with Office Hysteroscopy, run by Cairo University at 1 site in Egypt.
Trial summary
To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Office Hysteroscopy
- What is being tested?
- Dinoprostone 3Mg Vaginal Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2018to 28 Feb 2019
- Phase
- Phase 4
- 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
Who cannot join
- • Nulliparous patients
- patients with cervical pathology
- retroverted uterus (detected by transvaginal ultrasound)
- previous cervical surgery
- patients with severe vaginal bleeding
- allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
Read the detailed description
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
- Conditions
- Office Hysteroscopy
- Being tested
- Dinoprostone 3Mg Vaginal Tablet, placebo vaginal tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinoprostone 3Mg Vaginal TabletDrug
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
placebo vaginal tabletDrug
1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
| Study group | Role | What they receive |
|---|---|---|
| dinoprostone arm | Experimental | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. Receives: Drug: Dinoprostone 3Mg Vaginal Tablet |
| placebo | Placebo comparator | one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. Receives: Drug: placebo vaginal tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Measured: an expected average of 10 minutes
Secondary outcomes (2)
Intensity of pain
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Measured: 30 minutes after the procedure
Operative time
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Measured: an expected average 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start30 Sep 2018
- Primary completion30 Jan 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Office HysteroscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683914
- Sponsor's protocol ID
- vaginal dinoprostone
- Status last verified
- Mar 2019
- First submitted
- 22 Sep 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03683914
- Acronym / sponsor ID
- vaginal dinoprostone
- Conditions
- Office Hysteroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
Detailed description
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dinoprostone arm | Experimental | Drug: Dinoprostone 3Mg Vaginal Tablet1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. |
| placebo | Placebo comparator | Drug: placebo vaginal tabletone tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
Key exclusion criteria (6 listed)
- • Nulliparous patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dinoprostone 3Mg Vaginal Tablet1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy. | Drug | dinoprostone arm |
| placebo vaginal tablet1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy. | Drug | placebo |
Primary outcome
Intensity of pain
Time frame: an expected average of 10 minutes
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
2 secondary outcomes
Intensity of pain
Time frame: 30 minutes after the procedure
Operative time
Time frame: an expected average 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Related trials for Office Hysteroscopy
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Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
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Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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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.
AHMED SAMY, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dinoprostone 3Mg Vaginal Tablet in people with Office Hysteroscopy, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensity of pain (time frame: an expected average of 10 minutes). 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 26 Mar 2019.