Menopause Related ConditionsNCT03043690
A Pooled Analysis of the Data From Two Studies of Ammonium Succinate for Menopausal Symptoms
An observational study of Menopause Related Conditions, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo. Read more about this study
- Who is it for?
- Ages 42 to 60 years, women only
- Conditions the study is for
- Menopause Related Conditions
- What is being tested?
- Ammonium succinate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 1 siteRussia
- Study dates
- 11 Feb 2017to 30 May 2017
- Phase
- Observational
- 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 42 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Both studies chosen for pooled analysis recruited women with vasomotor and psychosomatic complaints, in the late phase of the menopausal transition and postmenopause according to the Stages of Reproductive Aging Workshop +10 classification.
Who may be able to join
- vasomotor and psychosomatic complaints
- ability to comply to study protocol
- signed informed consent
Who cannot join
- cancer (current or prior, based on medical history)
- conditions requiring planned hospitalization in the next 6 months;
- endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.);
- any surgeries within 1 year of the screening;
- hormone therapy within 6 months of the screening;
- psychiatric diseases;
- diabetes mellitus;
- taking other supplements or medications that may affect the climacteric syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of an Ammonium Succinate-based Dietary Supplement in Women With Menopausal Symptoms: a Pooled Analysis of the Data From Two Randomized, Multicenter, Double-blinded Placebo-controlled Clinical Trials.
This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.
Read the detailed description
Both studies were conducted previously and were randomized, double-blind and placebo-controlled. They followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. Both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected.
Naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. Many alternatives exist, generally acting via estrogen receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does not have phytoestrogenic ingredients.
- Conditions
- Menopause Related Conditions
- Being tested
- Ammonium succinate, Placebo
- Keywords
- menopause, ammonium succinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ammonium succinateDietary supplement
2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
PlaceboOther
2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Ammonium succinate | Patients in main pooled study group received 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. Receives: Dietary Supplement: Ammonium succinate | |
| Placebo | Patients in placebo study group received 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Feeling tense or nervous" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Difficulty in sleeping" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Excitable" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Attacks of panic" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Difficulty in concentrating" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Loss of interest in most things" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Crying spells" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Irritability" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Headaches" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Muscle or joint pains" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Breathing difficulties" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Hot flushes" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Sweating at night" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
"Loss of interest in sex" symptom (Greene Climacteric Scale)
Statistically significant reduction in designated symptom severity, compared between arms
Measured: Week 12
Secondary outcomes (3)
Spilberger-Hanin (Situational anxiety)
The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale
Measured: Week 12
Spilberger-Hanin (Personal anxiety)
The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale
Measured: Week 12
Spilberger-Hanin (Actual anxiety)
The decrease of actual anxiety, measured as statistically significant reduction of the score in corresponding subscale. Actual anxiety as a sum of situational and personal anxiety scores was introduced by Hanin in his modification of original State-Trait Anxiety Inventory.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start11 Feb 2017
- Primary completion3 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Menopause Related ConditionsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University
- Investigators
- Irina V Kuznetsova, Principal investigator, Sechenov First Moscow Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043690
- Sponsor's protocol ID
- AMSUCC2
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radzinskii VE, Kuznetsova IV, Uspenskaya YB, Repina NB, Gusak YK, Zubova OM, Burchakov DI, Osmakova AA. Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial. Gynecol Endocrinol. 2016 Oct;32(sup2):64-68. doi: 10.1080/09513590.2016.1232686.
PubMed 27759458Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012 Apr;19(4):387-95. doi: 10.1097/gme.0b013e31824d8f40.
PubMed 22343510Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
PubMed 19434881
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of an Ammonium Succinate-based Dietary Supplement in Women With Menopausal Symptoms: a Pooled Analysis of the Data From Two Randomized, Multicenter, Double-blinded Placebo-controlled Clinical Trials.
- ClinicalTrials.gov ID
- NCT03043690
- Acronym / sponsor ID
- AMSUCC2
- Conditions
- Menopause Related Conditions
- Keywords
- menopause, ammonium succinate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 6 Feb 2017 (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.
This study is a pooled statistical analysis of the data from 2 studies concerning efficacy of ammonium-succinate based dietary supplement. In both studies group 1 took the ammonium-succinate based dietary supplement and the group 2 took placebo.
Detailed description
Both studies were conducted previously and were randomized, double-blind and placebo-controlled. They followed very similar protocols, were of nearly identical design, had common inclusion and exclusion criteria. Both studies achieved statistical significance for ammonium succinate-based dietary supplement on most of pre-specified endpoints of Greene Climacteric Scale symptoms severity reduction at week 12. Nevertheless, some minor variation in the patient population, both within the studies (e.g., between different centres, as well as seasonal variability) and between the studies can be expected.
Naturally occuring estrogen deficiency over the course of the menopausal transition and postmenopause causes hot flushes and other psychosomatic and vasomotor symptoms. Menopausal hormone therapy is a method of choice, however in many cases it is contraindicated or unacceptable for other reasons. Many alternatives exist, generally acting via estrogen receptors (ER). The dietary supplement tested in the aforementioned studies contains ammonium succinate, which does not bind to ER, instead acting by supporting the Krebs cycle. It does not have phytoestrogenic ingredients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ammonium succinate | – | Dietary Supplement: Ammonium succinatePatients in main pooled study group received 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. |
| Placebo | – | Other: PlaceboPatients in placebo study group received 2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. |
Who may qualify
- Ages
- 42 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Both studies chosen for pooled analysis recruited women with vasomotor and psychosomatic complaints, in the late phase of the menopausal transition and postmenopause according to the Stages of Reproductive Aging Workshop +10 classification.
Key inclusion criteria (3 listed)
- vasomotor and psychosomatic complaints
- ability to comply to study protocol
- signed informed consent
Key exclusion criteria (8 listed)
- cancer (current or prior, based on medical history)
- conditions requiring planned hospitalization in the next 6 months;
- endocrine diseases with abnormal hormonal secretion (hypercorticism, hyperprplactinemia, hypersomatotropism, thyroid disorders et c.);
- any surgeries within 1 year of the screening;
- hormone therapy within 6 months of the screening;
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 |
|---|---|---|
| Ammonium succinate2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. | Dietary supplement | Ammonium succinate |
| Placebo2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days. | Other | Placebo |
Primary outcome
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Feeling tense or nervous" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Difficulty in sleeping" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Excitable" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Attacks of panic" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Difficulty in concentrating" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Loss of interest in most things" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Crying spells" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Irritability" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Feeling dizzy or faint" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Headaches" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Muscle or joint pains" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Breathing difficulties" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Hot flushes" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Sweating at night" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
"Loss of interest in sex" symptom (Greene Climacteric Scale)
Time frame: Week 12
Statistically significant reduction in designated symptom severity, compared between arms
3 secondary outcomes
Spilberger-Hanin (Situational anxiety)
Time frame: Week 12
Spilberger-Hanin (Personal anxiety)
Time frame: Week 12
Spilberger-Hanin (Actual anxiety)
Time frame: Week 12
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 20 Oct 2017.
- Background: PubMed 27759458Radzinskii VE, Kuznetsova IV, Uspenskaya YB, Repina NB, Gusak YK, Zubova OM, Burchakov DI, Osmakova AA. Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial. Gynecol Endocrinol. 2016 Oct;32(sup2):64-68. doi: 10.1080/09513590.2016.1232686.
- Background: PubMed 22343510Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012 Apr;19(4):387-95. doi: 10.1097/gme.0b013e31824d8f40.
- Background: PubMed 19434881Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
- Individual participant dataSharing planned: No
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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.
Irina V Kuznetsova principal investigator
Sechenov First Moscow Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause Related Conditions, run by I.M. Sechenov First Moscow State Medical University 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 3 inclusion and 8 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 20 Oct 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
"Heart beating quickly and strongly" symptom (Greene Climacteric Scale) (time frame: Week 12). The study lists 21 primary outcomes in all. 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 NCT03043690, which also lists 3 linked publications.
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 20 Oct 2017.