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Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

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ClinicalTrials.gov Identifier: NCT00572819
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : May 25, 2009
Helse Nord
Information provided by:
Ullevaal University Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Ripening Drug: Misoprostol Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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?
Study Start Date : January 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Arm Intervention/treatment
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.

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Britt-Ingjerd Nesheim, Gynaecological Department, Ullevål University Hospital, Oslo, Norway
ClinicalTrials.gov Identifier: NCT00572819     History of Changes
Other Study ID Numbers: 2007-004083-52
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: May 25, 2009
Last Verified: May 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