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Menopausal SyndromePhase 3UNCNTNCT01931748

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

A Phase 3 study testing MELSMON and UNCNT in people with Menopausal Syndrome, run by Unimed Pharmaceuticals at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Menopausal Syndrome
What is being tested?
MELSMON and UNCNT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
2 sitesSouth Korea
Study dates
Apr 2013to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Progestin intrauterine therapy ≥ 8 weeks
  • single injection of estrogen and progestin formulation transplant ≥3 month
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Inha Univ.Hospital,

    Incheon

  • Korea University Medical center Anam Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
MELSMON, UNCNT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MELSMONDrug

    Also called 6 times/ 12 days

  • UNCNTDrug

    Also called 6 times/ 12 days

Study groups in NCT01931748
Study groupRoleWhat they receive
UNCNTExperimental6 times/ 12 days
Receives: Drug: UNCNT
MELSMONActive comparator6 times/ 12 days
Receives: Drug: MELSMON

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kupperman index score

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

    Measured: baseline and 12days

Secondary outcomes (3)

  1. E2

    Change in blood serum of estradiol from baseline to 12days

    Measured: baseline and 12days

  2. FSH (Folic Stimulating Hormone)

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

    Measured: baseline and 12days

  3. Hot flushes

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

    Measured: baseline and 12days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931748
Sponsor's protocol ID
UNCNT3
Acronym
UNCNT
Status last verified
May 2014
First submitted
21 Aug 2013
Last updated
8 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MELSMON and UNCNT in people with Menopausal Syndrome, run by Unimed Pharmaceuticals at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kupperman index score (time frame: baseline and 12days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01931748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.

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