Etonogestrel Implants Protect Ovarian Reserve Function in Systemic Lupus Erythematosus

March 17, 2023 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etonogestrel implants group
Women will be subjected to etonogestrel implant (68mg) insertion.
Drug: Etonogestrel
Etongestrel implant will be implanted subcutaneously in the participant's non-dominant arm for one year
No Intervention: control group
This group of women will not be intervened.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year and three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of antral follicle
Time Frame: one year and three months
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
Follicle-stimulating hormone (FSH) serum level
Time Frame: one year and three months
The serum FSH levels of the two groups will be compared one year and three months after enrollment.
one year and three months
luteinizing hormone (LH) serum level
Time Frame: one year and three months
The serum LH levels of the two groups will be compared one year and three months after enrollment.
one year and three months
Estradiol (E2) serum level
Time Frame: one year and three months
The serum E2 levels of the two groups will be compared one year and three months after enrollment.
one year and three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

October 31, 2025

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022ZSLYEC-461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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