Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
1 other identifier
interventional
180
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedMarch 30, 2023
February 1, 2023
2.6 years
February 1, 2023
March 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of antral follicle
one year and three months
Follicle-stimulating hormone (FSH) serum level
one year and three months
luteinizing hormone (LH) serum level
one year and three months
Estradiol (E2) serum level
one year and three months
Study Arms (2)
Etonogestrel implants group
EXPERIMENTALWomen will be subjected to etonogestrel implant (68mg) insertion.
control group
NO INTERVENTIONThis group of women will not be intervened.
Interventions
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
Eligibility Criteria
You may qualify if:
- Systemic lupus erythematosus was confirmed
- years old
You may not qualify if:
- History of sex chromosome abnormalities
- History of abnormal thyroid function
- History of abnormal adrenal function
- History of pituitary disease
- History of sexual hormone drug use in the past 3 months
- History of ovarian tumors or invasive ovarian operations
- Pregnancy
- Have a birth plan in the next 1 year
- Ovarian failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
March 30, 2023
Study Start
April 1, 2023
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
March 30, 2023
Record last verified: 2023-02