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

Study of Non-inferiority UNCNT Versus MELSMON in Female With Menopausal Syndrome: Randomized Confirmatory Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Menopausal Syndrome
• Intervention / Treatment: Drug: UNCNT; Drug: MELSMON

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha Univ.Hospital,
  • Seoul, Korea, Republic of
    • Korea University Medical Center Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UNCNT; 6 times/ 12 days	Drug: UNCNT; Other Names: 6 times/ 12 days
Active Comparator: MELSMON; 6 times/ 12 days	Drug: MELSMON; Other Names: 6 times/ 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kupperman index score	Mean difference of single clinical symptom in Kupperman index from baseline to 12days	baseline and 12days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unimed Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: UNCNT3