GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide for lupus (sle).

The purpose of this study it to determine whether the use of a gonadotropin releasing hormone (GnRH)-agonist (depot-leuprolide acetate) during cyclophosphamide (CYC) therapy in women with rheumatic diseases will provide greater ovarian protection than placebo.

It had two arms (groups): LUPRON (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Of 16 participants who were screened, only 14 were randomized and only 7 participants actually completed the study.

Due to this low number, follicle stimulating hormone (FSH) levels were not obtained.

Secondary outcome measures that are not available include presence of menses and FSH.

Who Took Part

Enrollment: 14 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Female, post menarche, not menopausal. Ages 18-40 years inclusive at enrollment. Diagnosis consistent with a rheumatic or autoimmune disease requiring 3-6 months of daily or intermittent cyclophosphamide therapy. This may include, but is not limited to:. Isolated vasculitis of the central nervous system. Other autoimmune neurologic diseases requiring cyclophosphamide including transverse myelitis, peripheral neuropathies, multiple sclerosis, neuromyelitis optica, and retinal vasculitis.

The full record lists 19 inclusion and 10 exclusion criteria; among the exclusions: symptoms consistent with ovarian failure based on gynecologic evaluation and confirmatory laboratory testing; prior unilateral or bilateral oophorectomy; cervical intraepithelial neoplasia (cin 2, or more severe), that has not been adequately evaluated or is not being adequately treated.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

The Leuprolide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant and investigator.

It started in 2011-05 with completion listed for 2015-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Anti-mullerian Hormone (AMH) Measured as a Continuous Variable, Specifically Assessing the Intra-person Change From Study Entry (Day 0) to 6-month Post-intervention Visit (time frame: Day 0 to 6-month post-intervention visit).

It also tracked 4 secondary outcomes, for example Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,, Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4, Mean Antral Follicle Count (AFC) and Mean Ovarian Volume.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 14 people with lupus (sle).

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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