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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lupus Erythematosus, Systemic; Systemic Vasculitis; Isolated Angiitis of Central Nervous System; Lung Disease With Systemic Sclerosis; Lung Disease Interstitial Diffuse

Intervention: depot leuprolide acetate 3.75 mg (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Joseph Mccune

Official(s) and/or principal investigator(s):
William J McCune, M.D., Principal Investigator, Affiliation: Professor of Internal Medicine

Overall contact:
William Joseph McCune, M.D., Phone: 734-936-5554, Email: jmccune@umich.edu

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.

Clinical Details

Official title: GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: 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.

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

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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.

Locations and Contacts

William Joseph McCune, M.D., Phone: 734-936-5554, Email: jmccune@umich.edu

University of Michigan, Ann Arbor, Michigan 48109, United States; Recruiting
W Joseph McCune, M.D., Phone: 734-936-5561, Email: jmccune@umich.edu
Courtney Graft, Phone: 734-936-5562, Email: ccgraft@med.umich.edu
Joseph McCune, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Mary Anne Dooley, MD, Phone: 919-966-0558, Email: mary_dooley@med.unc.edu
Deborah MacDonald, Phone: 919-843-7868, Email: dsmacdon@email.unc.edu
Mary Ann Dooley, MD, Principal Investigator

The Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Brad Rovin, MD, Phone: 614-293-9979, Email: brad.rovin@osumc.edu
Melissa Brown, RN, BSN, Email: melissa.brown@osumc.edu
Brad Rovin, MD, Principal Investigator

West Penn Allegheny Health System, Pittsburgh, Pennsylvania 15224, United States; Not yet recruiting
Susan Manzi, MD, Phone: 412-359-3022, Email: smanzi@wpahs.org
Margie Ruffing, Phone: 412-578-5630, Email: mruffing@wpahs.org
Susan Manzi, MD, Principal Investigator

Additional Information

Starting date: May 2011
Last updated: July 1, 2013

Page last updated: August 23, 2015

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