Trial Outcomes & Findings for Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy (NCT NCT00925938)

NCT ID: NCT00925938

Last Updated: 2014-02-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Baseline to 18-24 hours

Results posted on

2014-02-13

Participant Flow

Premenopausal women requiring cervical priming prior to an in-office hysterectomy procedure were recruited at 5 sites in the US

Part 1 of the study included only women who had at least one vaginal delivery. There was no restriction on vaginal delivery status in Part 2 of the study. Part 1 participants were included in the MVPI 400 mcg cohort, MVPI 800 mcg cohort and the Placebo cohort. Part 2 participants were included in the MVPI 800 mcg cohort and the Placebo cohort.

Participant milestones

Participant milestones
Measure	MVPI 400 Mcg One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB).	MVPI Placebo One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Overall Study STARTED	9	25	17
Overall Study COMPLETED	9	25	17
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	25 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	40.8 years STANDARD_DEVIATION 6.57 • n=5 Participants	41.5 years STANDARD_DEVIATION 6.21 • n=7 Participants	42.0 years STANDARD_DEVIATION 5.86 • n=5 Participants	41.5 years STANDARD_DEVIATION 6.05 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	25 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	25 participants n=7 Participants	17 participants n=5 Participants	51 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 18-24 hours

Outcome measures

Outcome measures
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Change in Diameter of the Internal Cervical os From Baseline (Pre-treatment) to Just Prior to the Hysteroscopy Procedure (Post-treatment).	2.2 mm Standard Deviation 1.86	2.3 mm Standard Deviation 2.21	1.5 mm Standard Deviation 1.84

SECONDARY outcome

Timeframe: 18 - 24 hours

Population: A total of 46 subjects (90.2%) did not achieve their target dilatation after study drug removal (MVPI 400: 8 subjects; MVPI 800: 21 subjects; Placebo: 17 subjects). Forty-five subjects had additional dilatation attempted; additional dilatation was not attempted on one subject (MVPI 800) due to a protocol deviation (MVPI 800: 20 subjects).

Outcome measures

Outcome measures
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access Subjects requring additional dilatation	88.9 percentage of participants	84.0 percentage of participants	100 percentage of participants
Percent of Women Requiring Further Dilatation in Order to Allow Uterine Access Target Dilation Achieved following 2ndry dilation	100 percentage of participants	85.0 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: 18 - 24 hours

Outcome measures

Outcome measures
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Total Procedure Time From Insertion of the First Hegar Dilator to Completion of the Hysteroscopy Procedure;	3.26 minutes Standard Deviation 3.931	3.75 minutes Standard Deviation 5.888	2.32 minutes Standard Deviation 1.573

SECONDARY outcome

Timeframe: 18 - 24 hours

Outcome measures

Outcome measures
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Physician Assessment of Ease of Cervical Dilation; Inadequate	22.2 percentage of participants	36.0 percentage of participants	47.1 percentage of participants
Physician Assessment of Ease of Cervical Dilation; Adequate/ Correct Softness	66.7 percentage of participants	48.0 percentage of participants	52.9 percentage of participants
Physician Assessment of Ease of Cervical Dilation; Over Primed/ Too soft	11.1 percentage of participants	16.0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 9 days

Outcome measures

Outcome measures
Measure	MVPI 400 Mcg n=9 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 Participants One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 Participants One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Percentage of Participants With Adverse Events	100 Percentage of participants	92.0 Percentage of participants	82.4 Percentage of participants

Adverse Events

MVPI 400 Mcg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

MVPI 800 Mcg

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

MVPI Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MVPI 400 Mcg n=9 participants at risk One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study. misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure.	MVPI 800 Mcg n=25 participants at risk One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.	MVPI Placebo n=17 participants at risk One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study. placebo : placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/9 • All AEs were followed until resolution,the condition stabilized or for at least 30 days after d/c of the study drug, whichever came first. All AEs that were reported spontaneously up to 2 weeks after the subject completed the study were recorded.	4.0% 1/25 • Number of events 1 • All AEs were followed until resolution,the condition stabilized or for at least 30 days after d/c of the study drug, whichever came first. All AEs that were reported spontaneously up to 2 weeks after the subject completed the study were recorded.	0.00% 0/17 • All AEs were followed until resolution,the condition stabilized or for at least 30 days after d/c of the study drug, whichever came first. All AEs that were reported spontaneously up to 2 weeks after the subject completed the study were recorded.

Other adverse events

Additional Information

Clinical Development Support

Ferring Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All publications resulting from the clinical trial must be in a form that does not reveal technical information that the Sponsor considers confidential or proprietary. A copy of any abstract, presentation or manuscript proposed for publication must be submitted to the Sponsor for review at least 30 days before its submission. If deemed necessary for protection of proprietary information prior to patent filing, a further delay of 60 days is required before any publication is submitted.
Publication restrictions are in place

Restriction type: OTHER