Trial record 5 of 7 for:    Scleroderma AND (woman OR women OR female)

GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases (LUPRON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph Mccune, University of Michigan
ClinicalTrials.gov Identifier:
NCT01257802
First received: December 9, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Lupus Erythematosus, Systemic
Systemic Vasculitis
Isolated Angiitis of Central Nervous System
Lung Disease With Systemic Sclerosis
Lung Disease Interstitial Diffuse
Drug: depot leuprolide acetate 3.75 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with AMH of ≤1.0 ng/mL vs >1 ng/mL, presence of menses, presence of either an AMH level of >1 ng/mL OR antral follicle count of >4. Continuous measures include: antral follicle count (AFC), ovarian volume, and FSH. [ Time Frame: Various, per protocol ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LUPRON 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
Other Name: LUPRON depot 3.75 mg
Placebo Comparator: Placebo 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
Other Name: LUPRON depot 3.75 mg
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  1. Female, post menarche, not menopausal
  2. Ages 18-40 years inclusive at enrollment
  3. 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:

    • Systemic lupus
    • Sjogren's syndrome
    • Systemic vasculitis
    • 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
    • Behcet's syndrome
    • Scleroderma
    • Inflammatory myositis
    • Interstitial lung disease, other autoimmune pulmonary diseases requiring cyclophosphamide
    • Overlap connective tissue diseases not precisely fitting the above definitions clearly requiring cyclophosphamide for severe immune mediated organ damage
    • Rheumatoid vasculitis
  4. Patients will have planned cyclophosphamide treatment according to any one of the following regimens:

    • 3 to 6 months of daily oral cyclophosphamide: Lupron/placebo must be given within four (4) weeks of initiation of daily cyclophosphamide.
    • The Eurolupus regimen consisting of 6 fortnightly biweekly boluses of 500 mg cyclophosphamide: First dose of Lupron/placebo must be given 10 days prior to the second dose of cyclophosphamide
    • 3 to 6 monthly boluses of cyclophosphamide by the NIH regimen: First dose of Lupron/placebo must be given 10 days prior to the second dose of cyclophosphamide
  5. A satisfactory plan for contraception consistent with cyclophosphamide administration (when appropriate: depot progestins, IUD, combination oral contraception and/or dual barrier contraception).

Exclusion Criteria:

  1. Symptoms consistent with ovarian failure based on gynecologic evaluation and confirmatory laboratory testing
  2. Prior unilateral or bilateral oophorectomy
  3. Cervical intraepithelial neoplasia (CIN 2, or more severe), that has not been adequately evaluated or is not being adequately treated
  4. Contraindications to use of GnRH-a (e.g., undiagnosed abnormal uterine bleeding)
  5. Prior adverse or allergic reaction to GnRH-a
  6. A history of severe psychiatric disorders, particularly severe depression that is currently not adequately treated
  7. History of significant noncompliance with medical treatment
  8. 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.
  9. Pregnant or breastfeeding
  10. Significant thrombotic event requiring treatment that will not have received appropriate therapy for at least 4 weeks before initiation of study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257802

Contacts
Contact: William Joseph McCune, M.D. 734-936-5554 jmccune@umich.edu
Contact: Heather J Bryant, MSW 734 763-0562 hjbryant@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: W Joseph McCune, M.D.    734-936-5561    jmccune@umich.edu   
Contact: Courtney Graft    734-936-5562    ccgraft@med.umich.edu   
Principal Investigator: Joseph McCune, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mary Anne Dooley, MD    919-966-0558    mary_dooley@med.unc.edu   
Contact: Deborah MacDonald    919-843-7868    dsmacdon@email.unc.edu   
Principal Investigator: Mary Ann Dooley, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Brad Rovin, MD    614-293-9979    brad.rovin@osumc.edu   
Contact: Melissa Brown, RN, BSN       melissa.brown@osumc.edu   
Principal Investigator: Brad Rovin, MD         
United States, Pennsylvania
West Penn Allegheny Health System Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Susan Manzi, MD    412-359-3022    smanzi@wpahs.org   
Contact: Margie Ruffing    412-578-5630    mruffing@wpahs.org   
Principal Investigator: Susan Manzi, MD         
Sponsors and Collaborators
Joseph Mccune
Investigators
Principal Investigator: William J McCune, M.D. Professor of Internal Medicine
  More Information

No publications provided

Responsible Party: Joseph Mccune, Michael H. and Marcia S. Klein Professor of Rheumatic Diseases and Director, Lupus Clinic, University of Michigan
ClinicalTrials.gov Identifier: NCT01257802     History of Changes
Other Study ID Numbers: HUM00043071
Study First Received: December 9, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Fertility Agents, Female
Lung Diseases
Lupus Erythematosus, Systemic
Rheumatic Diseases
Sclerosis
Vasculitis
Lung Diseases, Interstitial
Systemic Vasculitis
Respiratory Tract Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Skin Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014