Climacteric SyndromePhase 2/3NCT02749695
Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women
A Phase 2/3 study testing Melsmon in people with Climacteric Syndrome, run by Inna I. Kovalenko at 1 site in Russia.
Trial summary
The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®. Read more about this study
- Who is it for?
- Ages 40 to 52 years, women only
- Conditions the study is for
- Climacteric Syndrome
- What is being tested?
- Melsmon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2013to Sep 2014
- Phase
- Phase 2/3
- 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 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- More than 40 years of age
- Irregular menstrual cycle
- Climacteric symptoms, including sleep disorders
- follicule-stimulating hormone >20 milli international units/ml -
Who cannot join
- Non-controlled hypertension (more than 140 mm Hg)
- Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke
- Diabetes mellitus
- Kidney and hepatic dysfunction
- Cancer
- Breast fibroadenomas, adenomas and cysts
Show all 10Show fewer
- Uterine fibroids with dominant nodule diameter ˃ 2 cm,
- Endometrial hyperplasia
- Individual drug idiosyncrasy
- Intake of any drugs for correction of climacteric symptoms and sleep disorders
Trial locations and contacts
1 site in 1 country.
Russia1 site
Scientific Center for Family Health and Human Reproduction Problems, Russia
Irkutsk, 664003
About this study
Official title: The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women
The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®.
Read the detailed description
There were 40 women under the observation, with mild and moderate symptoms of climacteric syndrome with sleep disorders (for that the investigators evaluated modified Kupperman Index).
All patients were randomized with the help of the envelope method with the allocation ratio of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received placebo during 4 months.
- Conditions
- Climacteric Syndrome
- Being tested
- Melsmon, Placebo
- Keywords
- menopause, climacteric syndrome, insomnia, placental extract
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelsmonDrug
Also called Melsmon Pharmaceutical Co., Ltd.
Placental extract Melsmon® (Japan): 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
PlaceboOther
Also called Normal Saline Solution
2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Melsmon) | Experimental | 20 women used placental extract Melsmon® (Japan), 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). Receives: Drug: Melsmon |
| Group 2 (placebo) | Placebo comparator | 20 patients used placebo (normal saline solution): 2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Changes of Kupperman Index
kupperman index scale (score)
Measured: 4 months after the treatment
Secondary outcomes (4)
Treatment-Related Changes of Menstrual Function
ultrasound assessment of endometrium growth (mm)
Measured: 4 months after the treatment
Treatment-Related Changes of Depression Symptoms
kupperman index questionnaire (score)
Measured: 4 months after the treatment
Treatment-Related Improvement in Skin Conditions
the questionnaire developed by the investigators (score)
Measured: 4 months after the treatment
Treatment-Related Changes of Sleep Quality
Pittsburgh Sleep Quality Index (score)
Measured: 4 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Climacteric SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inna I. Kovalenko
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Inna I. Kovalenko, Scientific Center for Family Health and Human Reproduction Problems, Russia
- Investigators
- Larisa V. Suturina, M.D., Study director, Scientific Center for Family Health and Human Reproduction Problems, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749695
- Sponsor's protocol ID
- Melsmon-913
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We plan to share all available IPD: age, body mass, character of menstrual disorder and climacteric syndromes, treatment regimen (for both experimental and placebo groups), Kupperman index, results of overall-health and sleep evaluation. Until the publications are available, any concerned party can contact the researcher Inna I. Kovalenko (innakov2010@yandex.ru).
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women
- ClinicalTrials.gov ID
- NCT02749695
- Acronym / sponsor ID
- Melsmon-913
- Conditions
- Climacteric Syndrome
- Keywords
- menopause, climacteric syndrome, insomnia, placental extract
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inna I. KovalenkoOther government
- Study start
- Oct 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®.
Detailed description
There were 40 women under the observation, with mild and moderate symptoms of climacteric syndrome with sleep disorders (for that the investigators evaluated modified Kupperman Index).
All patients were randomized with the help of the envelope method with the allocation ratio of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received placebo during 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Melsmon) | Experimental | Drug: Melsmon20 women used placental extract Melsmon® (Japan), 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). |
| Group 2 (placebo) | Placebo comparator | Other: Placebo20 patients used placebo (normal saline solution): 2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). |
Who may qualify
- Ages
- 40 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- More than 40 years of age
- Irregular menstrual cycle
- Climacteric symptoms, including sleep disorders
- follicule-stimulating hormone >20 milli international units/ml -
Key exclusion criteria (10 listed)
- Non-controlled hypertension (more than 140 mm Hg)
- Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke
- Diabetes mellitus
- Kidney and hepatic dysfunction
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelsmonAlso: Melsmon Pharmaceutical Co., Ltd.Placental extract Melsmon® (Japan): 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). | Drug | Group 1 (Melsmon) |
| PlaceboAlso: Normal Saline Solution2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total). | Other | Group 2 (placebo) |
Primary outcome
Treatment-Related Changes of Kupperman Index
Time frame: 4 months after the treatment
kupperman index scale (score)
4 secondary outcomes
Treatment-Related Changes of Menstrual Function
Time frame: 4 months after the treatment
Treatment-Related Changes of Depression Symptoms
Time frame: 4 months after the treatment
Treatment-Related Improvement in Skin Conditions
Time frame: 4 months after the treatment
Treatment-Related Changes of Sleep Quality
Time frame: 4 months after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Individual participant dataSharing planned: Yes. We plan to share all available IPD: age, body mass, character of menstrual disorder and climacteric syndromes, treatment regimen (for both experimental and placebo groups), Kupperman index, results of overall-health and sleep evaluation. Until the publications are available, any concerned party can contact the researcher Inna I. Kovalenko (innakov2010@yandex.ru).
Related trials for Climacteric Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa V. Suturina, M.D. study director
Scientific Center for Family Health and Human Reproduction Problems, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melsmon in people with Climacteric Syndrome, run by Inna I. Kovalenko at 1 site in Russia.
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 4 inclusion and 10 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Treatment-Related Changes of Kupperman Index (time frame: 4 months after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2016.