Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease

What Was Tested

This registered phase 2 trial tested Deslorelin.

It had two arms (groups): one (experimental) and Group 2 (continued survaillance) (active comparator).

Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months. Patients then undergo continued surveillance through 10 months.

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

More on the Plan

OUTLINE: GROUP 1: Patients receive deslorelin, estradiol, and testosterone intranasally once daily (QD) for 6 months.

GROUP 2: Patients receive deslorelin, estradiol, and testosterone intranasally QD for 10 months.

Patients then undergo continued surveillance through 10 months.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to women only aged from 21 years up to 48 years.

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

Examples of who could join: Patients must generally be in good health with lab values and physical examination within normal limits. Prior tubal ligation or willing to use a non-hormonal barrier method of contraception. Signed the Informed Consent Form document for this study in accordance with all Federal, State and Institutional regulations. Must be current non-smoker.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: gnrha treatment within 12 months of study entry; nasal polyposis, atrophic rhinitis, severe allergic or vasomotor rhinitis, or sinusitis requiring current treatment or treatment for more than 3 months in the previous year; pregnant or breast-feeding or have been so in the last six months.

How the Study Was Run

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

Being open-label, the Deslorelin study did not mask who received what.

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

It started in 2004-03-11 with completion listed for 2024-09-15.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Treatment effects and correlation of changes in morphometrics and biomarkers as assessed by mammogram and magnetic resonance image (MRI) densities on days 1 and 300 (time frame: Day 300).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Deslorelin in 11 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Deslorelin compound page, all human trials.