Health Condition 1: M30-M36- Systemic connective tissue disorders
Conditions
Interventions
Intervention1: Leuprolide acetate: Patients randomized to the intervention group will receive intramuscular injections of 3.75 mg depot leuprolide acetate every month in addition to the standard of ca
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult (aged 18-39 years), post menarche but premenopausal females 2. Suffering from severe manifestations of systemic autoimmune rheumatic diseases (lupus, systemic vasculitis, systemic sclerosis, inflammatory myositis, sjogren’s syndrome, mixed connective tissue disease, overlap connective tissue disease, CTD-ILD, or autoimmune neurological diseases requiring cyclophosphamide including myelitis and peripheral neuropathies) 3. Planned for starting/recently started (within last 1 week) on intravenous cyclophosphamide therapy by the treating physician
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Evidence of pre-existing ovarian failure on gynecological evaluation and laboratory testing (baseline FSH >40 mIU/mL) 3. Prior oophorectomy, hysterectomy, or pelvic irradiation 4. Contraindications for use of GnRH analogues including hypersensitivity, undiagnosed abnormal vaginal bleeding, pregnancy or lactation 5. Use of Euro-Lupus regimen of intravenous cyclophosphamide 6. On hormonal contraceptives 7. Patients unwilling to provide written informed consent 8. Severe thrombocytopenia 9. Baseline AMH
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The compare the change in anti-mullerian hormone (AMH) levels from baseline at 6 months between patients receiving leuprolide acetate (with CYC) versus no leuprolide acetate (CYC alone)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in AMH levels from baseline at 12 and 18 months between patients receiving leuprolide acetate with CYC versus CYC aloneTimepoint: 12 and 18 months;To compare the between-group change in antral follicular count (AFC), ovarian volume (OV), FSH and estradiol from baseline at 6, 12 and 18 monthsTimepoint: 6, 12 and 18 months;To compare the between-group rates of continuation/recovery of menstruation at 6, 12, and 18 monthsTimepoint: 6, 12 and 18 months;To compare the between-group rates of premature ovarian insufficiency at 12 and 18 monthsTimepoint: 12 and 18 months;To examine the serious and non-serious adverse events related to leuprolide use during the study periodTimepoint: Throughout the study period (18 months) | — |
Countries
India
Contacts
Public ContactSiddharth Jain
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed