InfertilityPhase 3NCT01612065
Optimum Misoprostol Dose Prior to Office Hysteroscopy
A Phase 3 study testing Misoprostol in people with Infertility and Abnormal Uterine and Vaginal Bleeding, Unspecified, run by Cairo University at 1 site in Egypt.
Trial summary
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Abnormal Uterine and Vaginal Bleeding, Unspecified, Recurrent Abortion
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2012to Apr 2013
- Phase
- Phase 3
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patient pre- or postmenopausal undergo office hysteroscopy.
- Age: from 20 to 60.
- BMI between 18 and 30.
Who cannot join
- PID or
- Heavy uterine bleeding
- Cervical malignancy.
- Symptoms suggestive of endometriosis .
- Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr alainy hospital, faculty of medicine , Cairo university
Cairo, 12211
About this study
Official title: The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.
Read the detailed description
The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications
- Being tested
- Misoprostol
- Keywords
- Office hysteroscopy, Cervical priming, Misoprostol
- Medical subject headings
- Infertility, Uterine Hemorrhage, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
200 ug
MisoprostolDrug
Misoprostol vaginally, 400 ug
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol vaginally, 200 ug | Active comparator | 200 ug misoprostol in the posterior vaginal fornix Receives: Drug: Misoprostol |
| Misoprostol vaginally, 400ug | Active comparator | Misoprostol in the posterior vaginal fornix Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score by VAS
Measured: 1year
Secondary outcomes (2)
Easiness
ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5;
Measured: 1year
Duration of the procedure
Duration of hysteroscopy in seconds
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed El-khayat, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612065
- Sponsor's protocol ID
- 2752012
- Status last verified
- Apr 2013
- First submitted
- 28 May 2012
- Last updated
- 11 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01612065
- Acronym / sponsor ID
- 2752012
- Keywords
- Office hysteroscopy, Cervical priming, Misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Jun 2012 (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.
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.
Detailed description
The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol vaginally, 200 ug | Active comparator | Drug: Misoprostol200 ug misoprostol in the posterior vaginal fornix |
| Misoprostol vaginally, 400ug | Active comparator | Drug: MisoprostolMisoprostol in the posterior vaginal fornix |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patient pre- or postmenopausal undergo office hysteroscopy.
- Age: from 20 to 60.
- BMI between 18 and 30.
Key exclusion criteria (5 listed)
- PID or
- Heavy uterine bleeding
- Cervical malignancy.
- Symptoms suggestive of endometriosis .
- Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
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 |
|---|---|---|
| Misoprostol200 ug | Drug | Misoprostol vaginally, 200 ug |
| MisoprostolMisoprostol vaginally, 400 ug | Drug | Misoprostol vaginally, 400ug |
Primary outcome
Pain score
Time frame: 1year
Pain score by VAS
2 secondary outcomes
Easiness
Time frame: 1year
Duration of the procedure
Time frame: 1year
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 11 Apr 2013.
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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.
Waleed El-khayat, M.D. 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 3 study testing Misoprostol in people with Infertility and Abnormal Uterine and Vaginal Bleeding, Unspecified, 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 3 inclusion and 5 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 11 Apr 2013. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain score (time frame: 1year). 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 11 Apr 2013.