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

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.

Study Overview

• Status: Completed
• Conditions: Menopause Related Conditions
• Intervention / Treatment: Dietary supplement: Ammonium succinate; Other: 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 Type: Observational
• Enrollment (Actual): 227

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119991
    • Sechenov First Moscow Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Dietary supplement: Ammonium succinate; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Irina V Kuznetsova, Sechenov First Moscow Medical University

Publications and helpful links

General Publications

• Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.
• Harlow 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2017
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): May 30, 2017

Study Registration Dates

• First Submitted: February 2, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: menopause; ammonium succinate
• Other Study ID Numbers: AMSUCC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No