Recruiting

GnRHa with Cyclophosphamide

Sponsor:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Code:

NCT05567198

Conditions

Systemic Lupus Erythematosus (Sle)

Primary Ovarian Insufficiency (Poi)

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Systemic Lupus Erythematosus (Sle)

Primary Ovarian Insufficiency (Poi)

Study ID

NCT05567198

Start date

Mar 3, 2023

Status verified date

Mar 23, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • POI [ Time Frame: End of study ]

Central Contacts and Locations

Central contacts

Locations

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

More Information

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Last update posted

Aug 4, 2026

Last verified

Mar 23, 2026

Keywords

  • Primary Ovarian Insufficiency (Poi)
  • Nephritis
  • Neuro-Psychiatric Lupus
  • Anti-Mullerian Hormone (Amh)
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2026-08-04.