Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05791799
• Other study ID #: 2022ZSLYEC-461
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: April 1, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiaoyan Liang
• Phone: 86 020-38250752
• Email: liangxy2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Etonogestrel
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Mullerian hormone (AMH) serum level	The serum AMH levels of the two groups will be compared one year and three months after enrollment.	one year and three months
Secondary	Number of antral follicle	The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment.	one year and three months
Secondary	Follicle-stimulating hormone (FSH) serum level	The serum FSH levels of the two groups will be compared one year and three months after enrollment.	one year and three months
Secondary	luteinizing hormone (LH) serum level	The serum LH levels of the two groups will be compared one year and three months after enrollment.	one year and three months
Secondary	Estradiol (E2) serum level	The serum E2 levels of the two groups will be compared one year and three months after enrollment.	one year and three months