← Human Trials & Peer-Reviewed Studies
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
Plain-language guide to NCT01873378: not phased randomized trial of Triptorelin, 84 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01873378
- Phase
- not phased
- Status
- completed
- Start
- 2013-01
- Completion (planned or actual)
- 2015-08
- Participants
- 84 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Uterine Myoma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Triptorelin.
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.
It had two arms (groups): GnRH agonist pretreatment (experimental) and one (no intervention).
The registry classes the interventions as drug.
Who Took Part
84 actual participants took part.
It was open to women only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: present or past history of cancer; presence of associated multiple polyps; presence of \> 2 myomas.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Because people in this Triptorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
In this single-blind Triptorelin study one party knew the assignments and the other did not.
Those kept unaware of assignments: investigator.
It started in 2013-01 with completion listed for 2015-08.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure (time frame: Just finished the surgical procedure).
It also tracked 1 secondary outcome, for example Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Triptorelin in 84 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.