NCT00953641

Brief Summary

The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure. The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2008

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 26, 2008

Last Update Submit

August 11, 2012

Conditions

MenorrhagiaEndometrial BiopsyCervical Ripening

Keywords

Vaginal MisoprostolCervical ripeningEndometrial biopsy

Outcome Measures

Primary Outcomes (1)

  • Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle

    1 year

Secondary Outcomes (4)

  • Evaluating participants discomfort during the procedure, using a pain scale

    1 year

  • Success rate of passage of the pipelle

    1 year

  • Adverse effects from medications

    1 year

  • Complications of the procedure

    1 year

Study Arms (4)

Pre-Menopausal 1

ACTIVE COMPARATOR

Pre-Menopausal group, receiving Misoprostol

Drug: Misoprostol

Pre-Menopausal 2

PLACEBO COMPARATOR

Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy

Drug: Placebo

Post-Menopausal 1

ACTIVE COMPARATOR

Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy

Drug: Misoprostol

Post-Menopausal 2

PLACEBO COMPARATOR

Placebo vaginal suppository prior to the endometrial biopsy

Drug: Placebo

Interventions

MisoprostolDRUG

Misoprostol 400ug, suspended in a base (Witepsol 15) as a vaginal suppository Single dose 12h or more prior to the procedure

Also known as: Cytotec
Post-Menopausal 1Pre-Menopausal 1
PlaceboDRUG

Witepsol 15 base, vaginal suppository, Single dose, 12h or more prior to the endometrial biopsy

Post-Menopausal 2Pre-Menopausal 2

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with abnormal uterine bleeding
  • Age over 35 years

You may not qualify if:

  • Pregnancy
  • Allergy to or contraindication to prostaglandin use
  • Active genital tract infections
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynecologic Consultants

Saskatoon, Saskatchewan, S7K 1N8, Canada

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation Disturbances

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Roger Pierson, PhD

    University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

    STUDY CHAIR

  • Anita Harding, MBChB

    University of Saskatchewan, Dept. of Obstetrics and Gynecology, College of Medicine

    PRINCIPAL INVESTIGATOR

  • Thirza Smith, MD, FRCS

    University of Saskatchewan, Dept. of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

  • Marilyn Davidson, FRCSC

    University of Saskatchewan, Dept. of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 6, 2009

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

CA(1)