Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial

What Was Tested

This registered phase 2 trial tested Leuprolide and Goserelin.

Both leuprolide and goserelin lower the amount of estrogen made by the body.

It had three arms (groups): Arm I (leuprolide) (experimental), Arm II (leuprolide) (experimental) and Arm III (goserelin) (experimental).

The registry classes the interventions as drug, other and procedure.

Who Took Part

The registry lists 75 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Female subject aged ≥ 18 years. Not planning bilateral salpingo-oophorectomy during the 6-month study duration. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: prior bilateral salpingo-oophorectomy; known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation); concomitant use of systemic or transdermal estrogen products.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2026-01-22 with completion listed for 2028-01-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml (time frame: During the first 24 weeks of therapy).

It also tracked 8 secondary outcomes, for example Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml, Proportion of participants with ultrasensitive estradiol concentration > 10 pg/ml, Change in FACT-ES Endocrine Symptom Subscale, Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire, Percentage of participants reporting discomfort of 6/10 or higher on the Discomfort of Injection questionnaire and Incidence of adverse events (AEs).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide and Goserelin in 75 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page and the Goserelin compound page, all human trials.