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Completed

NCT Number: NCT03043690

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

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.

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Key information

Conditions

Menopause Related Conditions

Age range

42 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Sechenov First Moscow Medical University

Moscow, 119991, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. "Heart beating quickly and strongly" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  2. "Feeling tense or nervous" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  3. "Difficulty in sleeping" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  4. "Excitable" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  5. "Attacks of panic" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  6. "Difficulty in concentrating" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  7. "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  8. "Loss of interest in most things" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  9. "Feeling unhappy or depressed" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  10. "Crying spells" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  11. "Irritability" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  12. "Feeling dizzy or faint" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  13. "Pressure or tightness in head or body" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  14. "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  15. "Headaches" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  16. "Muscle or joint pains" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  17. "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  18. "Breathing difficulties" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  19. "Hot flushes" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  20. "Sweating at night" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

  21. "Loss of interest in sex" symptom (Greene Climacteric Scale)

    Time frame: Week 12

    Statistically significant reduction in designated symptom severity, compared between arms

Secondary outcomes

  1. Spilberger-Hanin (Situational anxiety)

    Time frame: Week 12

    The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale

  2. Spilberger-Hanin (Personal anxiety)

    Time frame: Week 12

    The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

  3. Spilberger-Hanin (Actual anxiety)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 6, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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