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Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires

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ClinicalTrials.gov Identifier: NCT05567198
Recruitment Status : Recruiting
First Posted : October 5, 2022
Last Update Posted : June 13, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

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.


Condition or disease
Systemic Lupus Erythematosus (Sle) Primary Ovarian Insufficiency (Poi)

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
Actual Study Start Date : March 3, 2023
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : May 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Record Effects of CYC administration with GnRH-a on menstrual cycle [ Time Frame: End of study ]
    - Menses cycles will be classified as either regular (consistently having a period of normal duration each month) or irregular (frequent, infrequent, or absent periods). Classifications of irregular cycle subcategories will be provided, which include polymenorrhea (frequent periods with a cycle length <21 days), oligomenorrhea (infrequent menses with cycle length between 37 to 90 days), or amenorrhea (absence of a period for >90 days). - Menopausal signs and symptoms will include vaginal dryness, hot flashes, chills, sleeping disturbances, night sweats, mood changes, weight gain, loss of breast fullness, thinning hair, or dry skin. - Inability to conceive will be defined as 12 months of trying to conceive without success.

  2. SLE disease activity as measured by SELENA-SLEDAI score at the start of CYC treatment [ Time Frame: End of study ]
    These include SLE disease activity as measured by SELENA-SLEDAI score at the start of CYC treatment, damage index score as measured by SLICC/ACR DI, cumulative CYC dose, and age at the time of beginning CYC.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria
  • ELIGIBILITY CRITERIA:
  • INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05567198


Contacts
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Contact: Sarfaraz A Hasni, M.D. (301) 451-1599 hasnisa@mail.nih.gov

Locations
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United States, Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Recruiting
Bethesda, Maryland, United States, 20892
Contact: Sarfaraz Hasni, M.D.    301-451-1599    hasnisa@mail.nih.gov   
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Sarfaraz A Hasni, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publications:
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Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT05567198    
Other Study ID Numbers: 10001011
001011-AR
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: June 13, 2024
Last Verified: May 15, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ):
Primary Ovarian Insufficiency (Poi)
Nephritis
Neuro-Psychiatric Lupus
Anti-Mullerian Hormone (Amh)
Natural History
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Menopause, Premature
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Gonadal Disorders
Endocrine System Diseases