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Completed

NCT Number: NCT00572819

Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

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.

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Key information

Conditions

Cervical Ripening Dilatation, Pathologic Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Gynaecological Department, Ullevål University Hospital

Oslo, N-0450, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

Drug

Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Primary outcomes

  1. The primary outcome is the preoperative baseline cervical dilatation in the two treatment groups.

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Helse Nord

Registry information

Official study title

Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 13, 2007
Registry last updated
May 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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