Endometrial DisorderPhase 3NCT01805115
Misoprostol Administration Before Operative Hysteroscopy
A Phase 3 study testing Oral misoprostol, Sublingual misoprostol and Vaginal misoprostol in people with Endometrial Disorder, run by CHA University at 1 site in South Korea.
Trial summary
The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometrial Disorder
- What is being tested?
- Oral misoprostol, Sublingual misoprostol and Vaginal misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Feb 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic patients that were suspected as having intrauterine pathology, such as submucosal myoma, endometrial polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.
- Inclusion criteria were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -
Who cannot join
- Exclusion criteria included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
Read the detailed description
The route of administration of misoprostol for cervical dilatation prior to operative hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is more effective and less harmful for cervical dilation prior to operative hysteroscopy in premenopausal women. Furthermore, there have been no studies comparing among oral, sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
- Conditions
- Endometrial Disorder
- Being tested
- Oral misoprostol, Sublingual misoprostol, Vaginal misoprostol, Control
- Keywords
- hysteroscopy, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral misoprostolDrug
Also called two tablets of Cytotec (200 μg)
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
Sublingual misoprostolDrug
Also called two tablets of Cytotec (200 μg)
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
Vaginal misoprostolDrug
Also called two tablets of Cytotec (200 μg)
Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
ControlDrug
The control group was not given any cervical priming agents or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Oral misoprostol | Experimental | The oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery. Receives: Drug: Oral misoprostol |
| Sublingual misoprostol | Experimental | The sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery. Receives: Drug: Sublingual misoprostol |
| Vaginal misoprostol | Experimental | The vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery. Receives: Drug: Vaginal misoprostol |
| Control | Experimental | The no-misoprostol group did not administer the medication of misoprostol before the procedure Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the preoperative cervical width
The primary outcome measure was the preoperative cervical width at the time of operation. The cervical width was assessed by performing cervical dilation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.
Measured: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)
Secondary outcomes (1)
misoprostol-associated side effects
Measured: before the procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial DisorderStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, CHA University
- Investigators
- Taejong Song, MD, Principal investigator, Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805115
- Sponsor's protocol ID
- KNC13-005
- Status last verified
- Dec 2014
- First submitted
- 4 Mar 2013
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Song T, Kim MK, Kim ML, Jung YW, Yoon BS, Seong SJ. Effectiveness of different routes of misoprostol administration before operative hysteroscopy: a randomized, controlled trial. Fertil Steril. 2014 Aug;102(2):519-24. doi: 10.1016/j.fertnstert.2014.04.040. Epub 2014 May 23.
PubMed 24856464
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Oral, Sublingual and Vaginal Misoprostol Administration in Premenopausal Women Before Operative Hysteroscopy
- ClinicalTrials.gov ID
- NCT01805115
- Acronym / sponsor ID
- KNC13-005
- Conditions
- Endometrial Disorder
- Keywords
- hysteroscopy, misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Mar 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.
The objective of this study is to compare the efficacy of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
Detailed description
The route of administration of misoprostol for cervical dilatation prior to operative hysteroscopy can be oral, vaginal, or sublingual. However, it is still unclear which route is more effective and less harmful for cervical dilation prior to operative hysteroscopy in premenopausal women. Furthermore, there have been no studies comparing among oral, sublingual, and vaginal misoprostol, no medication (control) in these women. The objective of this study is to compare the efficacy and safety of oral, sublingual, vaginal, and no misoprostol prior to operative hysteroscopy in premenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral misoprostol | Experimental | Drug: Oral misoprostolThe oral group (misoprostol 400 ug) self-administered the medications orally 8-10 h before surgery. |
| Sublingual misoprostol | Experimental | Drug: Sublingual misoprostolThe sublingual group (misoprostol 400 ug) self-administered the medications sublingually 8-10 h before surgery. |
| Vaginal misoprostol | Experimental | Drug: Vaginal misoprostolThe vaginal group (misoprostol 400 ug) self-administered the medications vaginally 8-10 h before surgery. |
| Control | Experimental | Drug: ControlThe no-misoprostol group did not administer the medication of misoprostol before the procedure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Symptomatic patients that were suspected as having intrauterine pathology, such as submucosal myoma, endometrial polyp or other endometrial pathological findings based on the transvaginal ultrasound, were enrolled.
- Inclusion criteria were as follows: women who were of reproductive age (i.e., were premenopausal) and were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). -
Key exclusion criteria (1 listed)
- Exclusion criteria included any evidence of a contraindication to prostaglandins (history of severe asthma, glaucoma, preexisting severe cardiac disease, or renal failure), or allergy to prostaglandins, any sign of genital infection, presence of significant uterovaginal prolapse that could affect administration of vaginal tablets, history of cervical surgery, presence of space occupying lesions in endocervical canal, and treatment of GnRH agonist.
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 |
|---|---|---|
| Oral misoprostolAlso: two tablets of Cytotec (200 μg)Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation | Drug | Oral misoprostol |
| Sublingual misoprostolAlso: two tablets of Cytotec (200 μg)Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation | Drug | Sublingual misoprostol |
| Vaginal misoprostolAlso: two tablets of Cytotec (200 μg)Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation | Drug | Vaginal misoprostol |
| ControlThe control group was not given any cervical priming agents or placebo. | Drug | Control |
Primary outcome
the preoperative cervical width
Time frame: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)
The primary outcome measure was the preoperative cervical width at the time of operation. The cervical width was assessed by performing cervical dilation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until dilator could pass through the internal os without resistance. The largest one that could be passed was recorded as the initial cervical width.
1 secondary outcome
misoprostol-associated side effects
Time frame: before the procedures
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 25 Dec 2014.
- Derived from this study: PubMed 24856464Song T, Kim MK, Kim ML, Jung YW, Yoon BS, Seong SJ. Effectiveness of different routes of misoprostol administration before operative hysteroscopy: a randomized, controlled trial. Fertil Steril. 2014 Aug;102(2):519-24. doi: 10.1016/j.fertnstert.2014.04.040. Epub 2014 May 23.
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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.
Taejong Song, MD principal investigator
Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
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 Oral misoprostol, Sublingual misoprostol and Vaginal misoprostol in people with Endometrial Disorder, run by CHA University at 1 site in South Korea.
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 2 inclusion and 1 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 25 Dec 2014. 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 South Korea. 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?
the preoperative cervical width (time frame: just before the operation (From finish of anesthesic induction to introduction of a rigid resectoscope with 10-mm outer sheath diameter in uterine cavity)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805115, which also lists 1 linked publication.
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 25 Dec 2014.