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

Unimed Pharma

Status and phase

Completed

Phase 3

Conditions

Menopausal Syndrome

Treatments

Drug: UNCNT

Drug: MELSMON

Study type

Interventional

Funder types

Industry

Identifiers

NCT01931748

UNCNT3

Details and patient eligibility

About

The Purpose of this study is to evaluate in a randomized, double-blind, Parallel, Non-inferiority, Multicenter, the efficacy and safety of UNCNT in comparison to the active comparator of MELSMON in female having menopausal syndrome. Patients will be allocated randomly to receive either UNCNT or MELSMON.

Through the injection of UNCNT to female having menopausal disorder, efficacy in the improvement of the menopausal symptoms by Kupperman index is to be evaluated and compared with MELSMON.

Enrollment

104 patients

Sex

Female

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Woman ≥ 40 years old
Corresponding to one of the following criteria : Postmenopausal woman
1. spontaneous amenorrhea for 12 month
2. Blood serum of FSH concentration exceeds 40mlU/mL, spontaneous amenorrhea for 6month
3. passed for at least 6 weeks of bilateral ovariectomy
4. 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)
1. hormonal vaginal formulation (ring, cream, gels, etc) ≥ 1 weeks
2. estrogen single agent or estrogen/progestin-containing subcutaneous formulation ≥ 4 weeks
3. Oral estrogen or progestin therapy ≥ 8 weeks
4. Progestin intrauterine therapy ≥ 8 weeks
5. single injection of estrogen and progestin formulation transplant ≥3 month
6. 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