Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05021094
Eligibility Criteria:
Inclusion Criteria:
1. The women aged \<40 years old.
2. Serum basal follicle stimulating hormone (FSH) level ≥15 IU/L at least twice inspection (two occasions \>4 weeks apart). Rare menstruation or menopause for at least 4 months.
3. Individuals meeting the above criteria who voluntarily consented to study participation.
Exclusion Criteria:
1. Pregnant and lactating patients;
2. Patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \> 4cm or hysterectomy;
3. Patients with known or suspected breast cancer history and estrogen-dependent malignant tumor;
4. Patients with personal history of venous thromboembolism (VTE) or high risk of VTE (including body mass index \> 30 kg/m2, smoking and family history of thrombosis);
5. Patients with porphyria;
6. Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past three months;
8. Patients who suspect or have a history of alcohol and drug abuse;
9. Patients who are known to be allergic to the test drugs or their components;
10. The researchers determined that patients are not suitable for this trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT05021094
Study Brief:
Protocol Section:
NCT05021094