Lupus Erythematosus, SystemicPhase 3LUPRONNCT01257802
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
A Phase 3 study testing depot leuprolide acetate 3.75 mg in people with Lupus Erythematosus, Systemic and Systemic Vasculitis, run by Joseph Mccune at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Lupus Erythematosus, Systemic, Systemic Vasculitis, Isolated Angiitis of Central Nervous System
- What is being tested?
- depot leuprolide acetate 3.75 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
The Ohio State University
Columbus, Ohio, 43210
About this study
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.
Read the 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
- Being tested
- depot leuprolide acetate 3.75 mg, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depot leuprolide acetate 3.75 mgDrug
Also called LUPRON depot 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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| LUPRON | Active comparator | Monthly depot leuprolide acetate 3.75 mg injection 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 Receives: Drug: depot leuprolide acetate 3.75 mg |
| Placebo | Placebo comparator | Monthly placebo injection 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
Measured: Day 0 to 6-month post-intervention visit
Secondary outcomes (4)
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
AMH level ≤1.0 predicts onset of menopause within 5 years in normal women
Measured: baseline and 6 months
Number of Participants With Either an AMH Level of >1 ng/mL OR Antral Follicle Count of >4.
An AMH level of >1 ng/ml and/or an antral follicle count of >4 in either ovary is a strong predictor of residual ovarian function
Measured: baseline and 6 months
Mean Antral Follicle Count (AFC)
Mean antral follicle count (AFC) is the average number of follicles counted in each of 2 ovaries
Measured: baseline and 6 months
Mean Ovarian Volume.
Mean ovarian volume reflects the preservation of ovarian tissue despite exposure to cyclophosphamide; reduced ovarian size is documented in cyclophosphamide treated patients
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Mccune
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Joseph Mccune, University of Michigan
- Investigators
- William J McCune, M.D., Principal investigator, Professor of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257802
- Sponsor's protocol ID
- HUM00043071
- Other IDs
- 5R01HD066139
- Acronym
- LUPRON
- Status last verified
- May 2017
- First submitted
- 9 Dec 2010
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT01257802
- Acronym / sponsor ID
- LUPRON / HUM00043071
- Conditions
- Lupus Erythematosus, Systemic, Systemic Vasculitis, Isolated Angiitis of Central Nervous System, Lung Disease With Systemic Sclerosis, Lung Disease Interstitial Diffuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Joseph MccuneUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUPRON | Active comparator | Drug: depot leuprolide acetate 3.75 mgMonthly depot leuprolide acetate 3.75 mg injection 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 |
| Placebo | Placebo comparator | Drug: PlaceboMonthly placebo injection 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depot leuprolide acetate 3.75 mgAlso: LUPRON depot 3.75 mgMonthly 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 | LUPRON |
| PlaceboMonthly 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 |
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
Time frame: Day 0 to 6-month post-intervention visit
AMH was quantified in vitro a commercially available enzyme linked immunosorbent assay (ELISA) (Beckman Coulter; Marseille, France) was used for in vitro quantitative measurement of serum AMH.
4 secondary outcomes
Count of Patients With AMH of ≤1.0 ng/mL vs >1 ng/mL,
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 Antral Follicle Count (AFC)
Time frame: baseline and 6 months
Mean Ovarian Volume.
Time frame: baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J McCune, M.D. principal investigator
Professor of Internal Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing depot leuprolide acetate 3.75 mg in people with Lupus Erythematosus, Systemic and Systemic Vasculitis, run by Joseph Mccune at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.