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

Sponsor
Unimed Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01931748
Collaborator
(none)
104
Enrollment
2
Locations
2
Arms
12
Duration (Months)
52
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Study of Non-inferiority UNCNT Versus MELSMON in Female With Menopausal Syndrome: Randomized Confirmatory Clinical Trial
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Kupperman index score [baseline and 12days]

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

    Secondary Outcome Measures

    1. E2 [baseline and 12days]

      Change in blood serum of estradiol from baseline to 12days

    2. FSH (Folic Stimulating Hormone) [baseline and 12days]

      Change in blood serum of Follicle-Stimulating Hormone from baseline to 12days.

    3. Hot flushes [baseline and 12days]

      Change in frequency and mean differences of hot flushes from baseline to 12days.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inha Univ.Hospital, Incheon Korea, Republic of
    2 Korea University Medical center Anam Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Unimed Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Unimed Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01931748
    Other Study ID Numbers:
    • UNCNT3
    First Posted:
    Aug 29, 2013
    Last Update Posted:
    May 8, 2014
    Last Verified:
    May 1, 2014
    Additional relevant MeSH terms:
    Syndrome

    Study Results

    No Results Posted as of May 8, 2014