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

Completed

• Conditions: Menopause Related Conditions
• Interventions: Other: Placebo; Dietary Supplement: Ammonium succinate

• Registration Number: NCT03043690
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief 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.

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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Start: 2017-02-11
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-30
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 227

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ammonium succinate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Spilberger-Hanin (Actual anxiety)	Week 12	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.
Spilberger-Hanin (Situational anxiety)	Week 12	The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale
Spilberger-Hanin (Personal anxiety)	Week 12	The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

Trial Locations

Locations (1)

Sechenov First Moscow Medical University; 🇷🇺 Moscow, Russian Federation