Systemic Lupus ErythematosusPhase 2/3NCT05791799
Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
A Phase 2/3 study testing Etonogestrel in people with Systemic Lupus Erythematosus, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Etonogestrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Oct 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Systemic lupus erythematosus was confirmed
- 18-37 years old
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Have a birth plan in the next 1 year
- Ovarian failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Etonogestrel
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtonogestrelDrug
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
| Study group | Role | What they receive |
|---|---|---|
| Etonogestrel implants group | Experimental | Women will be subjected to etonogestrel implant (68mg) insertion. Receives: Drug: Etonogestrel |
| control group | No intervention | This group of women will not be intervened. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian hormone (AMH) serum level
The serum AMH levels of the two groups will be compared one year and three months after enrollment.
Measured: one year and three months
Secondary outcomes (4)
Number of antral follicle
The number of antral follicles will be recorded by transvaginal ultrasound and compared one year and three months after enrollment.
Measured: one year and three months
Follicle-stimulating hormone (FSH) serum level
The serum FSH levels of the two groups will be compared one year and three months after enrollment.
Measured: one year and three months
luteinizing hormone (LH) serum level
The serum LH levels of the two groups will be compared one year and three months after enrollment.
Measured: one year and three months
Estradiol (E2) serum level
The serum E2 levels of the two groups will be compared one year and three months after enrollment.
Measured: one year and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791799
- Sponsor's protocol ID
- 2022ZSLYEC-461
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized Controlled Clinical Study of Etonogestrel Implants to Protect Ovarian Reserve Function in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05791799
- Acronym / sponsor ID
- 2022ZSLYEC-461
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etonogestrel implants group | Experimental | Drug: EtonogestrelWomen will be subjected to etonogestrel implant (68mg) insertion. |
| control group | No intervention | –This group of women will not be intervened. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Systemic lupus erythematosus was confirmed
- 18-37 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtonogestrelEtongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year | Drug | Etonogestrel implants group |
Primary outcome
Anti-Mullerian hormone (AMH) serum level
Time frame: one year and three months
The serum AMH levels of the two groups will be compared one year and three months after enrollment.
4 secondary outcomes
Number of antral follicle
Time frame: one year and three months
Follicle-stimulating hormone (FSH) serum level
Time frame: one year and three months
luteinizing hormone (LH) serum level
Time frame: one year and three months
Estradiol (E2) serum level
Time frame: one year and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
Related trials for Systemic Lupus Erythematosus
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Etonogestrel in people with Systemic Lupus Erythematosus, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Liang (86 020-38250752, liangxy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Mullerian hormone (AMH) serum level (time frame: one year and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.