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Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis

Plain-language guide to NCT00286351: phase 4 non-randomized trial of Goserelin, endometriosis, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00286351
Phase
phase 4
Status
completed
Start
2005-01
Completion (planned or actual)
n/a
Participants
20
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Endometriosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Goserelin for endometriosis.

Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles. Couples with indication and wish for IVF/ICSI. Age of women: 20-40 years. Regular menstrual cycle within normal range (21-35 days). Body Mass Index (BMI): 18-30 kg/m2.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: history with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease; treatment of endometriosis with gnrh agonist during the last 3 month.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2005-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: size of endometriomas after 2½ month of combined downregulation.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Goserelin in 20 people with endometriosis.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page, Endometriosis research.

Our Notes on the Compound

Goserelin: A GnRH analog implant (Zoladex) used to lower sex-hormone levels in prostate and breast cancer and gynecologic conditions.

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.