Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

This study has been completed.
Sponsor:
Collaborator:
Helse Nord
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00572819
First received: December 12, 2007
Last updated: May 22, 2009
Last verified: May 2009

December 12, 2007
May 22, 2009
January 2008
May 2009   (final data collection date for primary outcome measure)
The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572819 on ClinicalTrials.gov Archive Site
  • Difference between baseline cervical dilatation at recruitment and preoperative dilatation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Women with cervical dilatation ≥ 5 mm. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Acceptability. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Number of dilatations judged as "difficult." [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Frequency of complications. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial
Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Cervical Ripening
  • Drug: Misoprostol
    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.
  • Drug: Placebo
    Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.
  • Active Comparator: Misoprostol
    Intervention: Drug: Misoprostol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00572819
2007-004083-52, 2007-004083-52
Yes
Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway
Ullevaal University Hospital
Helse Nord
Study Chair: Britt-Ingjerd Nesheim, MD, PhD University of Oslo, Faculty of Medicine
Ullevaal University Hospital
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP