Premature Ovarian Insuffiency
Conditions
Interventions
Kuntai:Kuntai Capsule
Femoston:Femoston 2/10
Kuntai+Femoston:Kuntai Capsule+Femoston 2/10
Sponsors
Beijing Obstetrics and Gynecologic Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. women younger than 40 years (which includes Turner Syndrome patients) and women older than 40 years, but with disease onset before the age of 40; 2. oligo/amenorrhea for at least 4 months, and 3. an elevated FSH level 25 IU/l on two occasions>4 weeks apart; 4. Willing to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) complete removal of bilateral ovaries; (2) currently or within 4 weeks prior to treatment (6 months for long-acting preparations); (3) currently or within 4 weeks prior to group treatment, POI treatment with Chinese medicine or/or other drugs; (4) previous and present history of estrogen-dependent tumors (such as breast cancer and endometrial cancer); (5) previous or current medical history of progesterone dependent tumors (e.g. meningioma); (6) any malignant or precancerous lesion (e.g. endometrial hyperplasia); (7) severe primary diseases, such as cardiovascular, liver, kidney and hematopoietic system, and any liver and kidney dysfunction 2.5 times above normal value; (8) previous or current history of arterial thromboembolism (e.g., angina, myocardial infarction) and/or venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism); (9) neurological or psychiatric disorders (such as clinical depression) that may interfere with adherence to the study procedures; (10) combined with osteoporosis; (11) diabetes develops into diabetic nephropathy in the late stage; (12) breast X-ray/breast ultrasound report of grade IV or above of bi-rads; (13) cervical cytology revealed malignant or precancerous lesions (14) patients with drug allergy or severe allergic constitution in this study; (15) patients who are participating in other clinical studies or have participated in other clinical studies in the past month; (16) hepatase - induced drugs, such as rifampicin, barbiturates, carbamazepine, chloraldobilin, butethasone, phenytoin, or pomeridone, may reduce the efficacy of estradiol/diprogesterone compounds (17) other patients whom the researchers determined were not suitable for the study; (18) known or suspected pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FSH;LH;AMH;E2;Kupperman Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| ultrasound;serum lipid level;blood glucose level;Insulin;COR;TSH;BMD(bone mineral density); | — |
Countries
China
Contacts
Public ContactXiangyan Ruan
Beijing Obstetrics and Gynecologic Hospital
Outcome results
None listed