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

Menopause Related Conditions Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043690
• Other study ID #: AMSUCC2
• Status: Completed
• Phase: N/A
• First received: February 2, 2017
• Last updated: October 18, 2017
• Start date: February 11, 2017
• Est. completion date: May 30, 2017

Study information

• Verified date: February 2017
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: May 30, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 42 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopause Related Conditions

Intervention

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.

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.

Locations

Country	Name	City	State
Russian Federation	Sechenov First Moscow Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Heart beating quickly and strongly" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Feeling tense or nervous" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Difficulty in sleeping" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Excitable" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Attacks of panic" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Difficulty in concentrating" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Loss of interest in most things" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Feeling unhappy or depressed" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Crying spells" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Irritability" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Feeling dizzy or faint" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Pressure or tightness in head or body" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Headaches" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Muscle or joint pains" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Breathing difficulties" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Hot flushes" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Sweating at night" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Primary	"Loss of interest in sex" symptom (Greene Climacteric Scale)	Statistically significant reduction in designated symptom severity, compared between arms	Week 12
Secondary	Spilberger-Hanin (Situational anxiety)	The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale	Week 12
Secondary	Spilberger-Hanin (Personal anxiety)	The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale	Week 12
Secondary	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