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

NCT01931748 | Completed Phase 3 DMC

• 1 other identifier: UNCNT3
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (1)

• Kupperman index score

  Mean difference of single clinical symptom in Kupperman index from baseline to 12days

  baseline and 12days

Secondary Outcomes (3)

• E2

  baseline and 12days

• FSH (Folic Stimulating Hormone)

  baseline and 12days

• Hot flushes

  baseline and 12days

Study Arms (2)

UNCNT

EXPERIMENTAL

6 times/ 12 days

Drug: UNCNT

MELSMON

ACTIVE COMPARATOR

6 times/ 12 days

Drug: MELSMON

Interventions

MELSMON DRUG

Also known as: 6 times/ 12 days

MELSMON

UNCNT DRUG

Also known as: 6 times/ 12 days

UNCNT

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unimed Pharmaceuticals: lead

Study Sites (2)

Inha Univ.Hospital,

Incheon, South Korea

Location

Korea University Medical center Anam Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 29, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

KR (2)