NCT01257802

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Joseph Mccune · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients will be women ages 18-40 with either a severe rheumatic disease requiring cyclophosphamide or interstitial lung disease requiring cyclophosphamide to be administered either daily orally; monthly intravenously; or intravenously every 2 weeks for 6 doses. Because cyclophosphamide treatment may be required urgently for some indications, study entry may occur before either the first or second dose of cyclophosphamide for patients receiving cyclophosphamide intravenously. 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.

Conditions

• Lupus Erythematosus, Systemic
• Systemic Vasculitis
• Isolated Angiitis of Central Nervous System
• Lung Disease With Systemic Sclerosis
• Lung Disease Interstitial Diffuse

Interventions

Type	Name	Description
DRUG	depot leuprolide acetate 3.75 mg	Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
DRUG	Placebo	Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2010-12-10
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

2 sites across 1 country: United States