Cervical RipeningPhase 3NCT00572819
Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial
A Phase 3 study testing Misoprostol in people with Cervical Ripening, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to May 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All postmenopausal (> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment
Who cannot join
- Women who do not wish to participate
- Women who are medically unfit for hysteroscopy
- Women who are medically unfit for participation in any clinical trial
- Women who do not have a medical indication for hysteroscopy
- Women who have previously had, or currently have breast or gynaecological cancer
- Women who have a medical contraindication for locally applied oestradiol
Show all 9Show fewer
- Women who are currently using hormone therapy
- Women who are unable to communicate in Norwegian, and
- Women with a known allergy to misoprostol
Trial locations and contacts
1 site in 1 country.
Norway1 site
Gynaecological Department, Ullevål University Hospital
Oslo, N-0450
About this study
Official title: Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?
The aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.
- Conditions
- Cervical Ripening
- Being tested
- Misoprostol, Placebo
- Keywords
- Hysteroscopy, Misoprostol, Postmenopausal women, Cervical ripening, Dilatation, Sequential trial, Estradiol
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
PlaceboDrug
Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Not described Receives: Drug: Misoprostol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
Measured: 24 hours
Secondary outcomes (5)
Difference between baseline cervical dilatation at recruitment and preoperative dilatation.
Measured: 14 days
Women with cervical dilatation ≥ 5 mm.
Measured: 14 days
Acceptability.
Measured: 14 days
Number of dilatations judged as "difficult."
Measured: 14 days
Frequency of complications.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RipeningStudies 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, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Investigators
- Britt-Ingjerd Nesheim, MD, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572819
- Sponsor's protocol ID
- 2007-004083-52
- Other IDs
- 2007-004083-52
- Status last verified
- May 2009
- First submitted
- 12 Dec 2007
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?
- ClinicalTrials.gov ID
- NCT00572819
- Acronym / sponsor ID
- 2007-004083-52
- Conditions
- Cervical Ripening
- Keywords
- Hysteroscopy, Misoprostol, Postmenopausal women, Cervical ripening, Dilatation, Sequential trial, Estradiol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Dec 2007 (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 aim of this study is to investigate whether 1000 micrograms of self-administered vaginal misoprostol 12 hours before operative hysteroscopy results in effective preoperative cervical ripening after two weeks pretreatment with 25 micrograms daily vaginal estradiol, compared to placebo (lactosum monohydricum) in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All postmenopausal (> one year since last menstruation) women who are referred to outpatient hysteroscopy with a medical indication for hysteroscopy, and who have given informed consent, will be eligible for study recruitment
Key exclusion criteria (9 listed)
- Women who do not wish to participate
- Women who are medically unfit for hysteroscopy
- Women who are medically unfit for participation in any clinical trial
- Women who do not have a medical indication for hysteroscopy
- Women who have previously had, or currently have breast or gynaecological cancer
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 |
|---|---|---|
| Misoprostol1000 micrograms of self-administered vaginal misoprostol compared to placebo 12 hours before operative hysteroscopy after two weeks pretreatment with 25 micrograms daily vaginal oestradiol. | Drug | Misoprostol |
| PlaceboVaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol. | Drug | Placebo |
Primary outcome
The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.
Time frame: 24 hours
5 secondary outcomes
Difference between baseline cervical dilatation at recruitment and preoperative dilatation.
Time frame: 14 days
Women with cervical dilatation ≥ 5 mm.
Time frame: 14 days
Acceptability.
Time frame: 14 days
Number of dilatations judged as "difficult."
Time frame: 14 days
Frequency of complications.
Time frame: 14 days
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 May 2009.
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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.
Britt-Ingjerd Nesheim, MD, PhD study chair
University of Oslo
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 Cervical Ripening, run by Ullevaal University Hospital at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 25 May 2009. 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 Norway. 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 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 primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. (time frame: 24 hours). 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 25 May 2009.