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

NCT03043690 | Completed

• 1 other identifier: AMSUCC2
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause Related Conditions

Keywords

menopause; ammonium succinate

Outcome Measures

Primary Outcomes (21)

• "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 Outcomes (3)

• Spilberger-Hanin (Situational anxiety)

  Week 12

• Spilberger-Hanin (Personal anxiety)

  Week 12

• Spilberger-Hanin (Actual anxiety)

  Week 12

Study Arms (2)

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

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

Interventions

Ammonium succinate DIETARY_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.

Ammonium succinate

Placebo OTHER

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

Eligibility Criteria

• Age: 42 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• vasomotor and psychosomatic complaints
• ability to comply to study protocol
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov First Moscow Medical University

Moscow, 119991, Russia

Location

Related Publications (3)

• 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.

  PMID: 27759458 BACKGROUND

• 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.

  PMID: 22343510 BACKGROUND

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

  PMID: 19434881 BACKGROUND

MeSH Terms

Interventions

Succinic Acid

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Irina V Kuznetsova

  Sechenov First Moscow Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: February 11, 2017
• Primary Completion: May 3, 2017
• Study Completion: May 30, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)