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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01257802
• Date of registration: 09/12/2010
• Prospective Registration: Yes
• Primary sponsor: Joseph Mccune
• Public title: GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases LUPRON
• Scientific title: GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
• Date of first enrolment: May 2011
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01257802
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: William J McCune, M.D.
• Affiliation: Professor of Internal Medicine

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Lung Disease With Systemic Sclerosis

Isolated Angiitis of Central Nervous System

Lung Disease Interstitial Diffuse

Systemic Vasculitis

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo

Drug: depot leuprolide acetate 3.75 mg

Primary Outcome(s)

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]

Secondary Outcome(s)

Mean Antral Follicle Count (AFC) [Time Frame: baseline and 6 months]

Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4. [Time Frame: baseline and 6 months]

Mean Ovarian Volume. [Time Frame: baseline and 6 months]

Count of Patients With AMH of =1.0 ng/mL vs >1 ng/mL, [Time Frame: baseline and 6 months]

Secondary ID(s)

HUM00043071

5R01HD066139

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institutes of Health (NIH)

Results

• Results available: Yes
• Date Posted: 27/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01257802