Systemic Lupus Erythematosus (Sle)NCT05567198
Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
An observational study of Systemic Lupus Erythematosus (Sle) and Primary Ovarian Insufficiency (Poi), run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus (Sle), Primary Ovarian Insufficiency (Poi)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2023to 31 May 2027
- Phase
- Observational
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 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
Sarfaraz Hasni, M.D., 301-451-1599, hasnisa@mail.nih.gov
About this study
Official title: Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires
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.
Read more
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.
Read the 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.
- Keywords
- Primary Ovarian Insufficiency (Poi), Nephritis, Neuro-Psychiatric Lupus, Anti-Mullerian Hormone (Amh), Natural History
- Medical subject headings
- Lupus Erythematosus, Systemic, Primary Ovarian Insufficiency, Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
POI
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.
Measured: End of study
Secondary outcomes (2)
Record Effects of CYC administration with GnRH-a on menstrual cycle
- 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.
Measured: End of study
SLE disease activity as measured by SELENA-SLEDAI score at the start of CYC treatment
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.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start3 Mar 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (Sle)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarfaraz A Hasni, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567198
- Sponsor's protocol ID
- 10001011
- Other IDs
- 001011-AR
- Status last verified
- 23 Mar 2026
- First submitted
- 4 Oct 2022
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman RC, Clarkin JF, Corn R, Aronoff MS, Hurt SW, Murphy MC. DSM-III and affective pathology in hospitalized adolescents. J Nerv Ment Dis. 1982 Sep;170(9):511-21. doi: 10.1097/00005053-198209000-00001. No abstract available.
PubMed 7108499Kiriakidou M, Cotton D, Taichman D, Williams S. Systemic lupus erythematosus. Ann Intern Med. 2013 Oct 1;159(7):ITC4-1. doi: 10.7326/0003-4819-159-7-201310010-01004. No abstract available.
PubMed 24081299Stamenovic B. [Effect of increased chloride on the spontaneous release of acetylcholine in the neuromuscular synapses of amphibia poisoned with Clostridium toxin Type A]. Vojnosanit Pregl. 1972 Mar;29(3):139-44. No abstract available. Serbian.
PubMed 4555317