GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Lupus Erythematosus, Systemic, Systemic Vasculitis, Isolated Angiitis of Central Nervous System, Lung Disease With Systemic Sclerosis, Lung Disease Interstitial Diffuse
In brief
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.
Key facts
- Study ID
- NCT01257802
- Run by
- Joseph Mccune
- People needed
- 14
- Starts
- 2011-05-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2017-06-27
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- 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
- Contraindications to use of GnRH-a (e.g., undiagnosed abnormal uterine bleeding)
- Prior adverse or allergic reaction to GnRH-a
- A history of severe psychiatric disorders, particularly severe depression that is currently not adequately treated
- History of significant noncompliance with medical treatment
- Patients with major risk factors for decreased bone mineral content such as chronic alcohol and/or tobacco use, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants that have not already been addressed with appropriate measures to preserve bone mass.
- Pregnant or breastfeeding
- Significant thrombotic event requiring treatment that will not have received appropriate therapy for at least 4 weeks before initiation of study drug.
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
- The Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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