Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial
Information source: Ullevaal University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Ripening
Intervention: Misoprostol (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Ullevaal University Hospital Official(s) and/or principal investigator(s):
Britt-Ingjerd Nesheim, MD, PhD, Study Chair, Affiliation: University of Oslo, Faculty of Medicine
Overall contact:
Britt-Ingjerd Nesheim, MD, PhD, Phone: +4722119813, Email: bine@ulleval.no
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.
Clinical Details
Official title: Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary outcome is the preoperative baseline cervical dilatation in the two
treatment groups.
Secondary outcome: Difference between baseline cervical dilatation at recruitment and preoperative dilatation.Women with cervical dilatation ≥ 5 mm. Acceptability. Number of dilatations judged as "difficult." Frequency of complications.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Britt-Ingjerd Nesheim, MD, PhD, Phone: +4722119813, Email: bine@ulleval.no
Gynaecological Department, Ullevål University Hospital, Oslo N-0450, Norway; Recruiting
Britt I Nesheim, MD, PhD, Phone: 4722119800, Email: Britt-Ingjerd.Nesheim@ulleval.no
Kevin Oppegaard, MD, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: December 2008
Last updated: September 15, 2008
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