| 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 ] |
| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Cervical Ripening |
- Drug: Misoprostol
- Drug: Placebo
|
| |
| |
| |
| 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 |
| Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway |
| 2007-004083-52, 2007-004083-52 |
| Ullevaal University Hospital |
| Helse Nord |
| Study Chair: |
Britt-Ingjerd Nesheim, MD, PhD |
University of Oslo, Faculty of Medicine |
|
|
| Ullevaal University Hospital |
| May 2009 |
