Cervical PrimingPhase 2NCT00925938
Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
A Phase 2 study testing misoprostol in people with Cervical Priming, run by Ferring Pharmaceuticals at 2 sites in United States.
Trial summary
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Priming
- What is being tested?
- misoprostol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy, pre-menopausal women;
- Women aged 18 years and above;
- Women who are undergoing an in-office procedure requiring uterine access along with a cervical dilatation of at least 5.5 mm;
- Women participating in Part 1 of study: Women who have had at least one vaginal delivery of at least 24 weeks gestation;
- Women with Pap smear results that do not require further evaluation for at least one year as assessed by the investigator. Note: 1) results must be from a Pap smear obtained within one year of screening; 2) if results are unavailable or not current, a Pap smear must be obtained and results reviewed prior to study inclusion; 3) if a Pap smear is to be performed at screening, subject must have a negative pregnancy test confirmed prior to the Pap smear collection;
- Women of child bearing potential: 1) Must have a negative urine pregnancy test at screening and just prior to study drug insertion, if this takes place on a different day from the screening visit; 2) Agree to use a highly effective method of birth control (defined as a low failure rate of less than 1% per year) as follows: implants, injectables, combined oral contraceptives, sexual abstinence from the date of the subject's last menstruation until completion of the follow-up visit, vasectomised partner or barrier method (condom with spermicide). Women in a same sex relationship do not need to meet this criterion if they confirm that there is no possibility of pregnancy;
Show all 9Show fewer
- Women who agree to refrain from vaginal intercourse while the study drug is in place;
- Women who agree to refrain from using any of the following from the day of study drug insertion until completion of the follow-up visit: feminine deodorant sprays/products, spermicides*, douches, condoms*, tampons, diaphragms or any other pharmaceutical or over the counter vaginal product. Barrier methods of contraception as indicated above (*) may be resumed following the dilatation procedure;
- Women who provide written informed consent.
Who cannot join
- Menopausal women;
- Women with menstrual periods lasting >10 days in duration;
- Baseline internal cervical os ≥ 3 mm;
- Women who have had prior endometrial ablation;
- Women who are breastfeeding;
- History or current diagnosis of glaucoma;
Show all 14Show fewer
- Women with clinically significant vaginal or cervical abnormality (e.g. symptoms of an infection) that would interfere with conducting study procedures prior to study drug insertion;
- Women who are currently undergoing treatment for cancer (basal cell carcinoma is acceptable);
- Body Mass Index (BMI) ≥ 50;
- Women participating in Part 1 of study: Women with a history of loop electrosurgical excision procedure (LEEP) or cold knife conization without an intervening vaginal delivery;
- Women with an intra-uterine device (IUD) in place, had an IUD removed within 30 days of the screening visit or scheduled to have an IUD inserted during the hysteroscopy procedure;
- Women using NuvaRing® for contraception;
- Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
- Unable to comply with the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Precision Trials
Phoenix, Arizona, 85032
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of the Misoprostol Vaginal Priming Insert for Women Requiring Cervical Priming Prior to a Hysteroscopy
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The study drug will be administered vaginally by a member of the clinical research team (Part I) or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy and at the follow up visit. The primary outcome measure is change in diameter of the internal cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the cervix better than placebo.
Read the detailed description
Prior to the hysteroscopy procedure, study staff will record the type of procedure that will be conducted and the desired cervical dilatation. The study drug will be removed in the office and then a vaginal examination will be performed for signs of irritation or trauma. The diameter of the internal os will then be assessed using Hegar dilators. The diameter of the internal os will be assessed by the largest size of Hegar dilator that can be inserted into the internal os without resistance. If the subject requires further dilatation prior to the procedure, this will be noted; additional dilatation is per clinician preference. The use of a tenaculum to allow insertion of the dilator(s)/ hysteroscope should be recorded. The time of starting and ending the hysteroscopy procedure will be documented. The start time of the hysteroscopy procedure is taken from the time of insertion of the first Hegar dilator to completion of the hysteroscopy procedure. Cervical priming assessment and safety will be recorded.
The subject will attend the clinic for follow-up assessments 7 days after the procedure.
Adverse events and concomitant medications will be recorded throughout the study.
The study will use an adaptive design, beginning with the MVPI 400 mcg and escalating or reducing the dose depending on results seen with a particular dose.
- Conditions
- Cervical Priming
- Being tested
- misoprostol, placebo
- Keywords
- Hysteroscopy, Cervical priming, Cervical dilatation, Misoprostol, Endoscopy, uterine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
misoprostolDrug
One vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol vaginal priming insert (MVPI) | Experimental | One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The initial dose is 400 mcg and dose will be adjusted between 100 - 1600 mcg after each study cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Receives: Drug: misoprostol |
| MVPI Placebo | Placebo comparator | One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).
Measured: Baseline to 18-24 hours
Secondary outcomes (4)
Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access
Measured: 18 - 24 hours
Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;
Measured: 18 - 24 hours
Physician Assessment of Ease of Cervical Dilation;
Measured: 18 - 24 hours
Percentage of Participants With Adverse Events
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical PrimingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925938
- Sponsor's protocol ID
- Miso-Gyn-201
- Status last verified
- Jan 2014
- First submitted
- 19 Jun 2009
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of the Misoprostol Vaginal Priming Insert for Women Requiring Cervical Priming Prior to a Hysteroscopy
- ClinicalTrials.gov ID
- NCT00925938
- Acronym / sponsor ID
- Miso-Gyn-201
- Conditions
- Cervical Priming
- Keywords
- Hysteroscopy, Cervical priming, Cervical dilatation, Misoprostol, Endoscopy, uterine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Jun 2009 (estimated)
- Results
- Posted 13 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vaginal Priming Insert (MVPI) for Women Requiring Cervical Priming prior to an in-office hysteroscopy procedure. Each subject will be randomized to receive one vaginal insert. The study drug will be administered vaginally by a member of the clinical research team (Part I) or insert herself (Part II) 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The internal os of the cervix will be measured at baseline, just prior to the hysteroscopy and at the follow up visit. The primary outcome measure is change in diameter of the internal cervical os from baseline (pre-treatment) to just prior to the hysteroscopy procedure (post-treatment). The hypothesis is that treatment with the MVPI will soften and dilate the cervix better than placebo.
Detailed description
Prior to the hysteroscopy procedure, study staff will record the type of procedure that will be conducted and the desired cervical dilatation. The study drug will be removed in the office and then a vaginal examination will be performed for signs of irritation or trauma. The diameter of the internal os will then be assessed using Hegar dilators. The diameter of the internal os will be assessed by the largest size of Hegar dilator that can be inserted into the internal os without resistance. If the subject requires further dilatation prior to the procedure, this will be noted; additional dilatation is per clinician preference. The use of a tenaculum to allow insertion of the dilator(s)/ hysteroscope should be recorded. The time of starting and ending the hysteroscopy procedure will be documented. The start time of the hysteroscopy procedure is taken from the time of insertion of the first Hegar dilator to completion of the hysteroscopy procedure. Cervical priming assessment and safety will be recorded.
The subject will attend the clinic for follow-up assessments 7 days after the procedure.
Adverse events and concomitant medications will be recorded throughout the study.
The study will use an adaptive design, beginning with the MVPI 400 mcg and escalating or reducing the dose depending on results seen with a particular dose.
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 vaginal priming insert (MVPI) | Experimental | Drug: misoprostolOne vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. The initial dose is 400 mcg and dose will be adjusted between 100 - 1600 mcg after each study cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). |
| MVPI Placebo | Placebo comparator | Drug: placeboOne vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, pre-menopausal women;
- Women aged 18 years and above;
- Women who are undergoing an in-office procedure requiring uterine access along with a cervical dilatation of at least 5.5 mm;
- Women participating in Part 1 of study: Women who have had at least one vaginal delivery of at least 24 weeks gestation;
- Women with Pap smear results that do not require further evaluation for at least one year as assessed by the investigator. Note: 1) results must be from a Pap smear obtained within one year of screening; 2) if results are unavailable or not current, a Pap smear must be obtained and results reviewed prior to study inclusion; 3) if a Pap smear is to be performed at screening, subject must have a negative pregnancy test confirmed prior to the Pap smear collection;
Key exclusion criteria (14 listed)
- Menopausal women;
- Women with menstrual periods lasting >10 days in duration;
- Baseline internal cervical os ≥ 3 mm;
- Women who have had prior endometrial ablation;
- Women who are breastfeeding;
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 |
|---|---|---|
| misoprostolOne vaginal insert containing 100, 200, 400, 800, 1200, 1600 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure. An adaptive design will be used to determine whether to escalate or reduce the dose, starting with MVPI 400 mcg. | Drug | Misoprostol vaginal priming insert (MVPI) |
| placeboplacebo | Drug | MVPI Placebo |
Primary outcome
Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).
Time frame: Baseline to 18-24 hours
4 secondary outcomes
Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access
Time frame: 18 - 24 hours
Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;
Time frame: 18 - 24 hours
Physician Assessment of Ease of Cervical Dilation;
Time frame: 18 - 24 hours
Percentage of Participants With Adverse Events
Time frame: 9 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cervical Priming
RecruitingPhase 2
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS≥1, hrHPV+ Oropharyngeal Cancer
Metastatic Oropharyngeal Carcinoma, Recurrent Oropharyngeal Carcinoma
Recruiting
Precise Robotically IMplanted Brain-Computer InterfacE
Tetraplegia/Tetraparesis, Quadriplegia
Recruiting
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Tetraplegia/Tetraparesis, Quadriplegia
Recruiting
UAE-PRIME: A Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Tetraplegia/Tetraparesis, Quadriplegia
Recruiting
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Tetraplegia/Tetraparesis, Quadriplegia
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.
Clinical Development Support study director
Ferring Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing misoprostol in people with Cervical Priming, run by Ferring Pharmaceuticals at 2 sites in United States.
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 9 inclusion and 14 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment). (time frame: Baseline to 18-24 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 13 Feb 2014.