NCT01873378

Brief Summary

The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

June 1, 2013

Last Update Submit

August 10, 2015

Conditions

Uterine Myoma

Keywords

Uterine myomaGnRHaHysteroscopyCold loop

Outcome Measures

Primary Outcomes (1)

  • To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.

    Just finished the surgical procedure.

Secondary Outcomes (1)

  • Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).

    Just finished the surgical procedure.

Study Arms (2)

GnRH agonist pretreatment

EXPERIMENTAL

triptorelin 3.75 mg, im, monthly, three times

Drug: Triptorelin 3.75 mg

No pharmacological treatment

NO INTERVENTION

Interventions

Triptorelin 3.75 mgDRUG
GnRH agonist pretreatment

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • present or past history of cancer
  • pregnancy
  • presence of associated multiple polyps
  • presence of \> 2 myomas
  • associated nonhysteroscopic surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbor Vitae Endoscopic Centre

Rome, Italy, 00191, Italy

Location

Related Publications (1)

  • Favilli A, Mazzon I, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Intraoperative Effect of Preoperative Gonadotropin-Releasing Hormone Analogue Administration in Women Undergoing Cold Loop Hysteroscopic Myomectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2018 May-Jun;25(4):706-714. doi: 10.1016/j.jmig.2017.11.011. Epub 2017 Nov 24.

    PMID: 29180306DERIVED

MeSH Terms

Conditions

Myofibroma

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • sandro gerli, MD

    University of Perugia, Perugia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2013

First Posted

June 10, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

IT(1)