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

Phase 3

Completed

• Conditions: Menopausal Syndrome
• Interventions: Drug: UNCNT; Drug: MELSMON

• Registration Number: NCT01931748
• Lead Sponsor: Unimed Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UNCNT	UNCNT	6 times/ 12 days
MELSMON	MELSMON	6 times/ 12 days

Primary Outcome Measures

Name	Time	Method
Kupperman index score	baseline and 12days	Mean difference of single clinical symptom in Kupperman index from baseline to 12days

Secondary Outcome Measures

Name	Time	Method
E2	baseline and 12days	Change in blood serum of estradiol from baseline to 12days
FSH (Folic Stimulating Hormone)	baseline and 12days	Change in blood serum of Follicle-Stimulating Hormone from baseline to 12days.
Hot flushes	baseline and 12days	Change in frequency and mean differences of hot flushes from baseline to 12days.

Trial Locations

Locations (2)

Inha Univ.Hospital,; 🇰🇷 Incheon, Korea, Republic of

Korea University Medical center Anam Hospital; 🇰🇷 Seoul, Korea, Republic of