A Pooled Analysis of the Data From Two Studies of Ammonium Succinate for Menopausal Symptoms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Menopause Related Conditions

Intervention / Treatment
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* Dietary Supplement: Ammonium succinate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vasomotor and psychosomatic complaints ability to comply to study protocol signed informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ammonium succinate<br>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. | Dietary Supplement: Ammonium succinate<br>* 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.<br>|
| Placebo<br>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. | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart beating quickly and strongly symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Feeling tense or nervous symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Difficulty in sleeping symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Excitable symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Attacks of panic symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Difficulty in concentrating symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Feeling tired or lacking in energy symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Loss of interest in most things symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Feeling unhappy or depressed symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Crying spells symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Irritability symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Feeling dizzy or faint symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Pressure or tightness in head or body symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Parts of body feeling numb or tingling symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Headaches symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Muscle or joint pains symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Loss of feeling in hands or feet symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Breathing difficulties symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Hot flushes symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Sweating at night symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 
| Loss of interest in sex symptom (Greene Climacteric Scale) | Statistically significant reduction in designated symptom severity, compared between arms | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spilberger-Hanin (Situational anxiety) | The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale | Week 12 | 
| Spilberger-Hanin (Personal anxiety) | The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale | 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. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, ammonium succinate