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Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial

NCT00572819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-05-25

No results posted yet for this study

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.

Conditions

  • Cervical Ripening

Interventions

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.

Sponsors & Collaborators

  • Helse Nord

    collaborator INDUSTRY

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Britt-Ingjerd Nesheim, MD, PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Norway

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572819 on ClinicalTrials.gov