Clinical trial NCT01931748: A Randomized, Double-Blind, Parallel, Non-Inferiority, Multicenter Trial Evaluate the Efficacy and Safety of UNCNT Compared to MELSMON in Female With Menopausal Syndrome
Official title: Study of Non-inferiority UNCNT Versus MELSMON in Female With Menopausal Syndrome: Randomized Confirmatory Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopausal Syndrome
Lead sponsor: Unimed Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 104
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Kupperman index score
timeFrame: baseline and 12days
Secondary outcomes:
measure: E2
timeFrame: baseline and 12days
measure: FSH (Folic Stimulating Hormone)
timeFrame: baseline and 12days
measure: Hot flushes
timeFrame: baseline and 12days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha Univ.Hospital,
city: Seoul
country: Korea, Republic of
facility: Korea University Medical center Anam Hospital
Study officials:
References: