Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Etonogestrel

Study type: Interventional

Funder types: Other

Identifiers

NCT05791799

2022ZSLYEC-461

Details and patient eligibility

About

This clinical trial aims to test in female patients with systemic lupus erythematosus (SLE). The main question it seeks to answer is whether etonogestrel implants can protect ovarian reserve function in patients with SLE. Participants will be randomly divided into a test group and a control group. The test group will be implanted subcutaneously with etongestrel for one year. Researchers won't intervene in the control group. After three months of drug-eluting, researchers will compare measures of ovarian reserve function in the test and control groups to see if etonogestrel implants can protect ovarian reserve function in patients with SLE.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Systemic lupus erythematosus was confirmed
2. 18-37 years old

Exclusion criteria

1. History of sex chromosome abnormalities
2. History of abnormal thyroid function
3. History of abnormal adrenal function
4. History of pituitary disease
5. History of sexual hormone drug use in the past 3 months
6. History of ovarian tumors or invasive ovarian operations
7. Pregnancy
8. Have a birth plan in the next 1 year
9. Ovarian failure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Etonogestrel implants group

Experimental group

Description:

Women will be subjected to etonogestrel implant (68mg) insertion.

Treatment:

Drug: Etonogestrel

control group

No Intervention group

Description:

This group of women will not be intervened.