Triptorelin for Ovary Protection in Childhood Onset Lupus

What Was Tested

The trial (phase 2) is built around Triptorelin for lupus (sle).

The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients.

The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease.

Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed.

It had five arms (groups): Triptorelin T1 (experimental), Triptorelin T2 (experimental), Triptorelin T3 (experimental), Triptorelin T4 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Lupus is an autoimmune disease that may harm all organs in the body and especially affects the kidney, brain, skin and lungs.

Only female lupus patients may participate in this study.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to women only aged from 9 years up to 21 years.

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

Examples of who could join: Females under the age of 21 and non-pregnant. Tanner stage of 2 or above as determined by physical examination of breast stage. Diagnosis with SLE using the updated American College of Rheumatology (ACR) Classification Criteria for SLE 1. Severe SLE requiring cyclophosphamide therapy. Bone mineral density z-score \> - 2.0.

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: male patients of any age; female patients with a tanner stage of 1; positive blood pregnancy test at screening or taking oral or injectable birth-control medications.

How the Study Was Run

It was run as a randomized, single-group and triple-blind study.

The lupus (sle) participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

As a double-blind Triptorelin study, the assignments were hidden from both participants and investigators until the end.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2003-06 with completion listed for 2014-03.

It ran at 10 sites in United States (9) and Brazil (1).

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 1 secondary outcome, for example Length of Time of Triptorelin Treatment to Achieve Ovarian Suppression.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 31 people with lupus (sle).

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Triptorelin compound page, Lupus (SLE) research.