Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

NCT00572819 | Completed Phase 3 DMC

• 1 other identifier: 2007-004083-52
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 postmenopausal women.

Conditions

Cervical Ripening

Keywords

Hysteroscopy; Misoprostol; Postmenopausal women; Cervical ripening; Dilatation; Sequential trial; Estradiol

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.

  24 hours

Secondary Outcomes (5)

• Difference between baseline cervical dilatation at recruitment and preoperative dilatation.

  14 days

• Women with cervical dilatation ≥ 5 mm.

  14 days

• Acceptability.

  14 days

• Number of dilatations judged as "difficult."

  14 days

• Frequency of complications.

  14 days

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Drug: Misoprostol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Misoprostol DRUG

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.

Misoprostol

Placebo DRUG

Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Women who are currently using hormone therapy
• Women who are unable to communicate in Norwegian, and
• Women with a known allergy to misoprostol

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Helse Nord: collaborator

Study Sites (1)

Gynaecological Department, Ullevål University Hospital

Oslo, N-0450, Norway

Location

MeSH Terms

Conditions

Dilatation, Pathologic

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Britt-Ingjerd Nesheim, MD, PhD

  University of Oslo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 25, 2009

Record last verified: 2009-05

Locations

NO (1)