Hysteroscopy After Pretreatment With Misoprostol and Estradiol Trial - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital Helse Nord
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00572819

Purpose

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 III

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Does Self-Administered Vaginal Misoprostol Result in Cervical Ripening in Postmenopausal Women After 14 Days Pre-Treatment With Estradiol?

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Misoprostol: Active Comparator	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: Placebo Comparator	Drug: Placebo Vaginal lactosum monohydricum administered 24 hours in postmenopausal women, compared to misoprostol after two weeks pretreatment with 25 micrograms daily vaginal oestradiol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572819

Contacts

Contact: Britt-Ingjerd Nesheim, MD, PhD	+4722119813	bine@ulleval.no
Contact: Kevin Sunde Oppegaard, MD	+4798644405	kevinsunde@yahoo.com.sg

Locations

Norway
Gynaecological Department, Ullevål University Hospital	Recruiting
Oslo, Norway, N-0450
Contact: Britt I Nesheim, MD, PhD 4722119800 Britt-Ingjerd.Nesheim@ulleval.no
Principal Investigator: Kevin Oppegaard, MD

Sponsors and Collaborators

Ullevaal University Hospital

Helse Nord

Investigators

Study Chair:

Britt-Ingjerd Nesheim, MD, PhD

University of Oslo, Faculty of Medicine

More Information

Responsible Party:	Gynaecological Department, Ullevål University Hospital, Oslo, Norway ( Britt-Ingjerd Nesheim )
Study ID Numbers:	2007-004083-52, 2007-004083-52
Study First Received:	December 12, 2007
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00572819
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Ullevaal University Hospital:

Hysteroscopy
Misoprostol
Postmenopausal women
Cervical ripening

Dilatation
Sequential trial
Estradiol

Study placed in the following topic categories:

Dilatation, Pathologic
Benzoates
Estradiol 3-benzoate
Estradiol valerate

Misoprostol
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol

Additional relevant MeSH terms:

Estrogens
Oxytocics
Contraceptive Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Gastrointestinal Agents

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Hormones
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on January 16, 2009