Cervical RipeningPhase 2Miso-Obs-203NCT00528255
Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
A Phase 2 study testing Misoprostol Vaginal Insert (MVI 100) in people with Cervical Ripening and Induction of Labor, run by Ferring Pharmaceuticals at 6 sites in United States.
Trial summary
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening, Induction of Labor
- What is being tested?
- Misoprostol Vaginal Insert (MVI 100)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women at ≥36 weeks 0 days inclusive gestation;
- Aged 18 years or older;
- Candidate for pharmacologic induction of labor;
- Singleton pregnancy;
- Baseline modified Bishop score <4 (see Appendix B);
- Nulliparous (nulliparous is defined as no previous births live or dead after 24 weeks gestation);
- Written informed consent.
Who cannot join
- Women with hemoglobin level < 11.0 g/dL (confirmed within one week of study drug insertion);
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g. bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or pregnancy inducted hypertension;
- Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
- Suspected or confirmed cephalopelvic disproportion and/or fetal malpresentation;
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- Diagnosed fetal abnormalities;
- Suspected or confirmed intrauterine growth retardation (less than 10% estimated fetal weight for dates);
- Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
- Receipt of NSAID (including aspirin) within 4 hours of study treatment;
- Ruptured membranes ≥48 hours prior to the start of treatment or suspected chorioamnionitis;
- Fever (oral or aural temperature > 37.5C);
- Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
- Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
- Any condition urgently requiring delivery;
- Unable to comply with the protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Long Beach Memorial Hospital
Long Beach, California, 90806
UCI Medical Center
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Paradise Valley Hospital
Phoenix, Arizona, 85032
Santa Clara Valley Medical Center
San Jose, California, 95128
Jordan Valley Hospital
West Jordan, Utah, 84088
About this study
Official title: A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.
Read the detailed description
PK study in women requiring cervical ripening.
- Conditions
- Cervical Ripening, Induction of Labor
- Being tested
- Misoprostol Vaginal Insert (MVI 100)
- Keywords
- cervical ripening, induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Vaginal Insert (MVI 100)Drug
Also called Cervical ripener
The MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Misoprostol Vaginal Insert (MVI 100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons.
Measured: 24 Hours
Secondary outcomes (1)
-The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
Why it stopped: PK portion will be included in a future protocol
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wininger, MD, Principal investigator, Precision TrialsArlen Jarrett, MD, Principal investigator, South Valley Women's ResearchDeborah Wing, MD, Principal investigator, UCI Medical Center/Long Beach Memorial HospitalRaymond Brown, MD, Principal investigator, Temple University HospitalJames Byrne, MD, Principal investigator, Santa Clara Valley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528255
- Sponsor's protocol ID
- Miso-Obs-203
- Acronym
- Miso-Obs-203
- Status last verified
- Jun 2012
- First submitted
- 10 Sep 2007
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Study of the Pharmacokinetics and Safety of the100 Mcg Misoprostol Vaginal Insert (MVI 100) in Women Requiring Cervical Ripening and Induction of Labor
- ClinicalTrials.gov ID
- NCT00528255
- Acronym / sponsor ID
- Miso-Obs-203 / Miso-Obs-203
- Conditions
- Cervical Ripening, Induction of Labor
- Keywords
- cervical ripening, induction of labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PK portion will be included in a future protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 12 Sep 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.
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.
Detailed description
PK study in women requiring cervical ripening.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Misoprostol Vaginal Insert (MVI 100) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women at ≥36 weeks 0 days inclusive gestation;
- Aged 18 years or older;
- Candidate for pharmacologic induction of labor;
- Singleton pregnancy;
- Baseline modified Bishop score <4 (see Appendix B);
Key exclusion criteria (16 listed)
- Women with hemoglobin level < 11.0 g/dL (confirmed within one week of study drug insertion);
- Women in active labor;
- Presence of uterine or cervical scar or uterine abnormality e.g. bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
- Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or pregnancy inducted hypertension;
- Severe pre-eclampsia marked by CNS findings, HELLP syndrome, or other end-organ affliction;
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 |
|---|---|---|
| Misoprostol Vaginal Insert (MVI 100)Also: Cervical ripenerThe MVI 100 is misoprostol 100 mcg, formulated in a sustained release, nonbiodegradeable hydrogel polymer, with a polyester knit retrieval tape; IV oxytocin is permitted ad lib 30 minutes following removal of the MVI assuming no contraindications. | Drug | 1 |
Primary outcome
The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons.
Time frame: 24 Hours
1 secondary outcome
-The levels of misoprostol acid in plasma at time of removal, and 30 and 60 minutes post removal. -Assess all adverse events.
Time frame: 24h
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
Steven Wininger, MD principal investigator
Precision Trials
Arlen Jarrett, MD principal investigator
South Valley Women's Research
Deborah Wing, MD principal investigator
UCI Medical Center/Long Beach Memorial Hospital
6 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 Vaginal Insert (MVI 100) in people with Cervical Ripening and Induction of Labor, run by Ferring Pharmaceuticals at 6 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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 18 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons. (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 18 Jun 2012.