Clinical trial
A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
Name
2022ZSLYEC-461
Description
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.
Trial arms
Trial start
2023-04-01
Estimated PCD
2025-10-31
Trial end
2025-10-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Etonogestrel
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
Arms:
Etonogestrel implants group
Size
180
Primary endpoint
Anti-Mullerian hormone (AMH) serum level
one year and three months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2023-03-30
1 organization