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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030424
Receipt No. R000034401
Scientific Title Study of mechanisms by which Melsmon improves climacteric symptoms
Date of disclosure of the study information 2018/12/31
Last modified on 2019/07/01

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Basic information
Public title Study of mechanisms by which Melsmon improves climacteric symptoms
Acronym Mechanisms of action of Melsmon
Scientific Title Study of mechanisms by which Melsmon improves climacteric symptoms
Scientific Title:Acronym Mechanisms of action of Melsmon
Region
Japan

Condition
Condition Climacteric syndrome
Classification by specialty
Medicine in general Obsterics and gynecology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To determine by analyzing simplified menopausal indices (SMI) whether climacteric symptoms in women in perimenopausal or postmenopausal period are improved by subcutaneous injection of Melsmon.
2. To measure various biochemical indices in peripheral blood that will be collected from participants before and after Melsmon injection
3. To determine correlations between improvement of SMI scores and parameters for oxidative stress conditions in blood
4. To explore plasma proteins that are involved in the improvement of SMI scores.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes This was a crossover study including a total of 31 patients which consisted 17 subjects of group 1 and 14 subjects in group 2. A first phase of the study consisted of blood collection and simplified menopausal indices (SMI) from patients of group 1 (or group 2) was measured for each patient before receiving Melsmon (or saline as a placebo). Patients of group 1 then received subcutaneous injection of Melsmon twice a week at a dose of 4 mL, irrespective of body weight, for 3 weeks consecutively. The primary outcome was to investigate the changes of SMIs following Melsmon injection and blood was also collected from all patients. After a washout period of one month blood samples were again collected and SMIs were determined from all patients of group 1. Next, injection of saline as a control of Melsmon was performed for l7 patients of group 1 by the same protocol stated above followed by a month of washout period. 14 patients of group 2 were treated with the same protocol stated group 2 followed by a first injection of saline.
SMI scores before and after Melsmon or saline injections were analyzed using a standard crossover statistical analysis by SPSS.
Key secondary outcomes A second outcome was to determine whether the levels of alteration of SMI scores are correlated with the levels of oxidative stress or with any other biochemical parameters in peripheral blood. About 10 mL blood was collected from all the subjects of both groups before and after the injection of Melsmon or saline. Plasma and serum were prepared from the blood immediately. Oxidative/anti-oxidative parameters were analyzed and it was determined whether there are correlations between SMI scores and the parameters relevant to oxidative/anti-oxidative states. To determine whether plasma proteins that were related to alterations of SMI scores, 6 biochemical parameters including Alb, ALT, CK, AMY, HDL, and LDL in serum were analyzed.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Crossover comparison study 1;
Group 1: Phase 1 consisted of SMI measurement and blood collection prior to the initiation of the study, which was followed by Melsmon injection (4 mL/day x 2 days/week for 3 weeks). After completion of Melsmon injection, SMI scores were measured and blood samples were collected from all patients. Phase 2 included a month washout period, which was subsequently followed by the determination of SMI scores and blood collection. Saline was then injected into patients using the same protocol for Melsmon administration. Then SMI scores were again measured and blood samples were collected.
Interventions/Control_2 Crossover comparison study 2:
Group 2: Phase 1 consisted of SMI measurement and blood collection prior to the initiation of the study, which was followed by saline injection (4 mL/day x 2 days/week for 3 weeks). After completion of saline injection, SMI scores were measured and blood samples were collected from all patients. Phase 2 included a month washout period, which was subsequently followed by the determination of SMI scores and blood collection. Melsmon was then injected into patients using the same protocol for saline administration. Then SMI scores were again measured and blood samples were collected.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
25 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria Participants of the study were selected from outpatients, who are diagnosed climacteric syndrome or its related disorders with SMI scores higher than 29. Eligible participants should provide a written informed consent prior to participating in the study and must not have any of the exclusion criteria stated below.
Key exclusion criteria The following subjects.
1) pregnant subjects or those with desire of pregnancy.
2) subjects of breast feeding
3) subjects taking female hormone medications
4) subjects taking medications affecting female hormone levels
5) subjects taking placental extract-containing drugs or supplements.
6) female hormone drugs or drugs affecting the female hormone state used within a month.
7) difficult of providing a written informed consent.
8) suffering from severe systemic disorders.
9) subjects who are under certain medical conditions and judged by doctor incompatible with the study.
10) subjects who have experience of drug allergy.
11) subjects who are judged inappropriate by doctors in the clinic.
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)Mahiko Nagase, 2)Ryoki Takahashi
Organization 1)Kichijoji Traditional Chinese Medicine Clinic.
2)Melsmon Pharmaceutical Co., Ltd.
Division name 1) Clinic. 2) Research Laboratory.
Zip code
Address 1) 1-13-6-5F Kichijoji, Musashino-shi, Tokyo 180-0004, Japan 2)Horikoshi building 3F, 39-1, 2 chome Ikebukuro, Toshima-ku, Tokyo 171-0014, Japan
TEL 0422-20-4110
Email mahiko@kca.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mahiko Nagase
Organization Kichijoji Traditional Chinese Medicine Clinic.
Division name Clinic
Zip code
Address 1-13-6-5F Kichijoji, Musashino-shi, Tokyo 180-0004, Japan
TEL 0422-20-4110
Homepage URL
Email mahiko@kca.biglobe.ne.jp

Sponsor
Institute Melsmon Pharmaceutical Co., Ltd
Research Laboratory
Institute
Department

Funding Source
Organization Melsmon Pharmaceutical Co., Ltd
Research Laboratory
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 吉祥寺中医クリニック(東京都)/Kichijoji Traditional Chinese Medicine Clinic (Tokyo).
メルスモン製薬株式会社(東京都)/Melsmon Pharmaceutical Co., Ltd (Tokyo)
Research Laboratory.

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
2017 Year 01 Month 31 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2018 Year 04 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 04 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 16 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034401

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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