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Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

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

Condition Intervention Phase
Cervical Ripening Drug: Misoprostol Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?

Resource links provided by NLM:

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups. [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Difference between baseline cervical dilatation at recruitment and preoperative dilatation. [ Time Frame: 14 days ]
  • Women with cervical dilatation ≥ 5 mm. [ Time Frame: 14 days ]
  • Acceptability. [ Time Frame: 14 days ]
  • Number of dilatations judged as "difficult." [ Time Frame: 14 days ]
  • Frequency of complications. [ Time Frame: 14 days ]

Estimated Enrollment: 100
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol 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.
Placebo Comparator: Placebo Drug: Placebo
Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00572819

Gynaecological Department, Ullevål University Hospital
Oslo, Norway, N-0450
Sponsors and Collaborators
Ullevaal University Hospital
Helse Nord
Study Chair: Britt-Ingjerd Nesheim, MD, PhD University of Oslo
  More Information

Responsible Party: Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway Identifier: NCT00572819     History of Changes
Other Study ID Numbers: 2007-004083-52
Study First Received: December 12, 2007
Last Updated: May 22, 2009

Keywords provided by Ullevaal University Hospital:
Postmenopausal women
Cervical ripening
Sequential trial

Additional relevant MeSH terms:
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics processed this record on September 19, 2017