Clinical Observation on Kuntai Capsule in Treating Early-onset Ovarian Hypofunction

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the efficacy and safety of Kuntai capsule alone or combined with hormone therapy in improving ovarian function in POI patients (including subclinical stage).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Nantong University
• Treatments: Dydrogesterone; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

1. The women aged <40 years old.

2. Rare menstruation or menopause for at least 4 months.

3. 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.

4. 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.