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Compares treatment options for Assisted Reproductive Technology
Official title A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects
ClinicalTrials.gov ID: NCT06599528
What this study is testing
What is T-R (Test-Reference drug)?
T-R (Test-Reference drug) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for assisted reproductive technology.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Healthy female people aged 20 to 40 years old (including boundary values).
- Weight not less than 45.0 kg, body mass index within the range of 19.0\~26.0 kg/m2 (including boundary values).
- Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
- The levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T)...
- LH levels \<5 IU/L, FSH levels \<4 IU/L at Day -1.
You likely can't join if
- Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
- Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
- Previously or currently suffering from the following diseases: hypothalamic or pituitary tumors, unexplained ovarian enlargement or cyst, Abnormal...
- Ectopic pregnancy within 3 months prior to screening.
- Presence of clinically significant acute or chronic infection at screening or enrolment。
- Presence of localised disease affecting the hypodermic site, or inability to tolerate hypodermic injections。
See the full eligibility criteria
- Healthy female people aged 20 to 40 years old (including boundary values).
- Weight not less than 45.0 kg, body mass index within the range of 19.0\~26.0 kg/m2 (including boundary values).
- Menstrual cycle regularity, or menstrual regularity before taking oral contraceptives (25-34 days, including boundary values).
- The levels of follicle stimulating hormone(FSH), luteinizing hormone(LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) detected within 2-3 days after the last menstrual period before the first...
- LH levels \<5 IU/L, FSH levels \<4 IU/L at Day -1.
- Allergy or suspected allergy to any component of the experimental drug, control drug, GnRH, GnRH analogs used in this study.
- Use of any LH preparation, human menopausal gonadotropin (hMG) or human chorionic gonadotropin (hCG) preparation within 3 months prior to screening.
- Previously or currently suffering from the following diseases: hypothalamic or pituitary tumors, unexplained ovarian enlargement or cyst, Abnormal uterine bleeding of unknown etiology, malignant tumors of the ovaries...
- Ectopic pregnancy within 3 months prior to screening.
- Presence of clinically significant acute or chronic infection at screening or enrolment。
- Presence of localised disease affecting the hypodermic site, or inability to tolerate hypodermic injections。
- Difficulty in blood collection or inability to tolerate venipuncture, or history of needle or blood sickness.
- Prescription medications taken within 14 days or 5 half-lives prior to screening or over-the-counter medications (including proprietary and herbal medications) taken within 7 days or 5 half-lives prior to screening .
- A history of chronic or serious illness or disease of the liver, kidneys, gastrointestinal tract, endocrine system, cardiovascular, neurological, metabolic, haematological, respiratory, or autoimmune systems or an...
- Abnormalities in vital signs, physical examination, laboratory tests (routine blood, blood biochemistry, urinalysis, coagulation, thyroid function), 12-lead electrocardiogram, liquid-based thin-layer cytometry (TCT)...
- Positive tests for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and syphilis spirochete antibody.
- History of mental illness, substance abuse, drug dependence, or positive substance abuse screen (morphine, THC, methamphetamine, MDMA, ketamine) on the day of admission.
- Excessive consumption of tea, coffee or caffeinated beverages in the 3 months prior to screening.
- Drinking an average of more than 14 standard units of alcohol per week in the three months prior to screening, or inability to abstain from alcohol during the test period, or a positive breathalyser test result on the...
- Smoke at least 5 cigarettes per day in the 3 months prior to screening or not be able to stop using any tobacco-based products during the trial.
- Participated in a clinical trial of another drug within 28 days prior to screening and used the test drug, or participated in a clinical trial of a medical device within 1 month prior to screening.
- History of blood donation or bleeding \>400 ml within 3 months prior to screening.
- During pregnancy or breastfeeding, or a positive pregnancy test result. The subject (or his/her partner) is planning to have children (including sperm and egg donation) throughout the trial period and for 3 months after...
- people who withdrew from the trial for their own reasons and who, in the opinion of the investigator, were otherwise unsuitable to participate in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.