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Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide
Plain-language guide to NCT03475758: phase 2 randomized trial of Goserelin, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03475758
- Phase
- phase 2
- Status
- status unknown
- Start
- 2018-03
- Completion (planned or actual)
- 2020-03
- Participants
- 100 (estimated)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Ovarian Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Goserelin.
These include premature menopause and infertility in young pre-menopausal women.
It had two arms (groups): chemotherapy without goserelin (no intervention) and chemotherapy with goserelin (experimental).
These patients will receive their chemotherapy without addition of Goserelin.
These patients will receive their chemotherapy with addition of Goserelin.
The registry classes the interventions as drug.
More on the Plan
In this phase II trial, patients will be randomly assigned, in a 1:1 ratio, to standard adjuvant or neoadjuvant chemotherapy with the GnRH agonist goserelin (goserelin group) or to chemotherapy without goserelin (chemotherapy alone group).
Follow up: All patients will be followed for at least 1 year clinically monthly and by laboratory assessment by hormonal profile (FSH, LH, E2) every 6 months.
Who Took Part
100 planned participants were the target.
It was open to women only.
Healthy volunteers were not accepted; participants needed the condition being studied.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Goserelin 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.
Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.
It started in 2018-03 with completion listed for 2020-03.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: compare rate of ovarian failure at 1 year between the two treatment groups (time frame: 1 year).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Goserelin in 100 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Goserelin compound page, all human trials.
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.