Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05567198 |
Recruitment Status :
Recruiting
First Posted : October 5, 2022
Last Update Posted : April 30, 2024
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | October 4, 2022 | ||||
First Posted Date | October 5, 2022 | ||||
Last Update Posted Date | April 30, 2024 | ||||
Actual Study Start Date | March 3, 2023 | ||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
POI [ Time Frame: End of study ] The primary outcome variable is POI, and we want to determine whether GnRH-a coadministration with CYC protects against POI incidence in pre-menopausal SLE females. The age of menopause onset will be collected from previous medical records or survey responses and compared across all three groups. Onset of menopause prior to the age of 40 will be considered POI, whereas menopause onset beyond the age of 40 will be considered natural menopause.
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires | ||||
Official Title | Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires | ||||
Brief Summary | Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not. Objective: To find out whether GnRHa can help protect women s ovaries during CYC. Eligibility: Women under age 40 years starting CYC treatment with or without GnRHa. Design: This study will do 2 things: It will conduct patient surveys. It will collect data from medical records. Participants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility. Participants can take the survey in 4 ways: On paper, sent through the mail. Online, in a secure web page managed by the NIH. By phone. In person, during a routine visit to the NIH clinic. The survey will take about 30 minutes. Participants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments. Researchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections. |
||||
Detailed Description | Study Description: SLE patients with life-threatening lupus manifestations are often treated with cyclophosphamide (CYC), which has known cytotoxic effects on ovarian reserve. Co-administration of Gonadotropinreleasing hormone agonist (GnRHa) is suggested to protect ovaries from the cytotoxic effects of CYC but there is lack of data to support this. We hypothesize that the co-administration of a GnRH agonist for the duration of CYC therapy will exert protective effects on ovarian reserve and function in SLE females. We plan to do a patient survey and a retrospective data collection to compare ovarian function in subjects who received CYC with GnRHa to those who received CYC without GnRHa. Objectives: Primary Objective: Determine the effectiveness of GnRH-a in preventing primary ovarian insufficiency (POI) in female SLE patients getting cyclophosphamide treatment. Secondary Objectives: Determine the effects of SLE disease activity, damage accrual, cumulative dose of cyclophosphamide and other demographic and clinical variables in preventing primary ovarian insufficiency. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | This is a single-site study which will include women with SLE (diagnosed according to the revised American College of Rheumatology criteria). The participants will be stratified in 3 groups: Group 1: SLE patients receiving CYC alone, Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a), Group 3: Control subjects, Age-matched female SLE patients without a history of reproductive disorders. The subjects screening and retrospective data collection and will be performed by searching electronic medical records for SLE patients treated under SLE Natural History and Pathogenesis Study (Protocol # 94-AR-0066) at the NIH Clinical Center. This protocol and protocol # 94-AR-0066 are under the same PI. | ||||
Condition |
|
||||
Intervention | Not Provided | ||||
Study Groups/Cohorts |
|
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | May 31, 2024 | ||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
SLE females <40 years at the beginning of CYC treatment without GnRH-a cotreatment. -EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone Females >40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs). -INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months. SLE females <40 years at the beginning of CYC treatment with GnRH-a cotreatment. -EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months. Females >40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs. -Group: Control subjects. Age-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a. |
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT05567198 | ||||
Other Study ID Numbers | 10001011 001011-AR |
||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ) | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | April 25, 2024 |