Trial record 10 of 21 for:    Open Studies | "Uterine Myomectomy"

GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Azienda Ospedaliera S. Maria della Misericordia
Sponsor:
Information provided by (Responsible Party):
Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier:
NCT01873378
First received: June 1, 2013
Last updated: June 8, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine whether GnRH agonist treatment before cold loop hysteroscopic myomectomy is effective in reducing operative time, fuid absorption and difficulty of the procedure.


Condition Intervention
Uterine Myoma
Drug: Triptorelin 3.75 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera S. Maria della Misericordia:

Primary Outcome Measures:
  • Minutes (surgical procedure time), milliliters (fluid absorption during the procedure), 0-3 scale (difficulty of the procedure), 0-3 scale (quality of image) [ Time Frame: 5 minutes after the end of the surgical procedure. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GnRH agonist pretreatment
triptorelin 3.75 mg, im, monthly, three times
Drug: Triptorelin 3.75 mg
No Intervention: No pharmacological treatment

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy
  • premenopausal status

Exclusion Criteria:

  • present or past history of cancer
  • pregnancy
  • presence of associated multiple polyps
  • presence of > 2 myomas
  • associated nonhysteroscopic surgical procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873378

Contacts
Contact: Sandro Gerli, MD 368434624 ext +39 gerber@unipg.it
Contact: Alessandro Favilli, MD 3292270705 ext +39 alessandrofavilli.mail@gmail.com

Locations
Italy
Arbor Vitae Endoscopic Centre Recruiting
Rome, Italy, 00191
Contact: Ivan Mazzon, MD       i.mazzon@arborvitae.it   
Principal Investigator: Ivan Mazzon, MD         
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia
Investigators
Principal Investigator: sandro gerli, MD University of Perugia, Perugia, Italy
  More Information

No publications provided

Responsible Party: Sandro Gerli, Assistant Professor, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT01873378     History of Changes
Other Study ID Numbers: GnRHa hysteroscopic myomectomy
Study First Received: June 1, 2013
Last Updated: June 8, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Azienda Ospedaliera S. Maria della Misericordia:
Uterine myoma
GnRHa
Hysteroscopy
Cold loop

Additional relevant MeSH terms:
Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Triptorelin Pamoate
Deslorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014