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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05791799
Other study ID # 2022ZSLYEC-461
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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