A Randomized, Double-Blind, Parallel, Non-Inferiority, Multicenter Trial Evaluate the Efficacy and Safety of UNCNT Compared to MELSMON in Female With Menopausal Syndrome

Inclusion criteria

• Woman ≥ 40 years old
• Corresponding to one of the following criteria : Postmenopausal woman

• spontaneous amenorrhea for 12 month
• Blood serum of FSH concentration exceeds 40mlU/mL, spontaneous amenorrhea for 6month
• passed for at least 6 weeks of bilateral ovariectomy
• History of bilateral hysterectomy pasted at least 6week and blood serum of FSH more than 40mLU/ml
• Confirmed using a hot flashes recorded daily diary at visit 2: More 3-4 (times/ per day) moderate or severe flush at least a day or occurrence of more than 20 times a week to check flush
• Kupperman Index Score ≥ 15 point
• Serum Estradiol ≤ 30pg/mL
• Able to communicate to conduct the clinical trial according to the protocol
• Informed consent by oneself

Exclusion criteria

• Allergic to drugs or any ingredient
• Psychological menopausal disorder
• History of carcinoma such as liver cancer etc
• In the investigator's judgment, which will be unable to participate in this study

• uncontrolled hypertensive(170/110mmHg more), severe disease (eg., of the cardiovascular, liver, kidney) or diabetic mellitus
• History of hysterectomy or bilateral ovariectomy within 6 weeks
• Patients whose blood serum AST/ALT, bilirubin and creatinine are more two times the normal maximum rate.
• Receiving hormone therapy such as estrogen, progestin or hormone of this class within a month
• Patients are participated in other clinical trials, and then receiving investigational product within 3 months.
• Usage of prohibit combination dug
• history of alcohol and drug abuse
• Washout requirement for hormone therapy such as estrogen or products involved like estrogen/progestin component ( If who has washout period of following criteria, the subject can participate in this study)

• hormonal vaginal formulation (ring, cream, gels, etc) ≥ 1 weeks
• estrogen single agent or estrogen/progestin-containing subcutaneous formulation ≥ 4 weeks
• Oral estrogen or progestin therapy ≥ 8 weeks
• Progestin intrauterine therapy ≥ 8 weeks
• single injection of estrogen and progestin formulation transplant ≥3 month
• injection of progestin or estrogen pellet method ≥ 6 month
• In woman ≥40 age, known or suspicion of breast cancer at Breast angiographic and normal pregnancy breast test within 9 month; history of breast cancer; Family history of breast cancer in one generation
• In Thickness of uterine intima ≥5mm as determined by TUVS, known or suspicion of endometrial hyperplasia or endometrial cancer by performing the endometrial biopsy
• known or suspicion of Cervical cancer in pap test ( pap smear)
• otoscleorsis
• Taking rifampicin induced liver microsome enzyme ( eg., Barbiturates, Hydantion, carbamazepine, mepeu donkey mate, John diphenyl butadiene)
• Jaundice, Dubin-Johnson syndrome or Rotor syndrome
• Vaginal bleeding for unknown reason
• Sickle cell anemia
• Severe metabolic disorder (eg., porphyria..)
• Thrombotic phlebitis, thrombosis, embolism patients, or those patients with a history
• Cerebral, coronary altery disease
• Thyroid disease, infectious disease
• Experience of using placenta drug
• Other circumstances that make the investigator expect an incomplete study participation of the patient