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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03043690
First Posted: February 6, 2017
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University
  Purpose
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.

Condition Intervention
Menopause Related Conditions Dietary Supplement: Ammonium succinate Other: Placebo

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
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.

Resource links provided by NLM:


Further study details as provided by Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University:

Primary Outcome Measures:
  • "Heart beating quickly and strongly" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Feeling tense or nervous" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Difficulty in sleeping" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Excitable" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Attacks of panic" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Difficulty in concentrating" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Loss of interest in most things" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Feeling unhappy or depressed" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Crying spells" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Irritability" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Feeling dizzy or faint" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "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

  • "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

  • "Headaches" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Muscle or joint pains" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "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

  • "Breathing difficulties" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Hot flushes" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Sweating at night" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms

  • "Loss of interest in sex" symptom (Greene Climacteric Scale) [ Time Frame: Week 12 ]
    Statistically significant reduction in designated symptom severity, compared between arms


Secondary Outcome Measures:
  • Spilberger-Hanin (Situational anxiety) [ Time Frame: Week 12 ]
    The decrease of situational anxiety, measured as statistically significant reduction of the score in corresponding subscale

  • Spilberger-Hanin (Personal anxiety) [ Time Frame: Week 12 ]
    The decrease of personal anxiety, measured as statistically significant reduction of the score in corresponding subscale

  • 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.


Enrollment: 227
Actual Study Start Date: February 11, 2017
Study Completion Date: May 30, 2017
Primary Completion Date: May 3, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043690


Locations
Russian Federation
Sechenov First Moscow Medical University
Moscow, Russian Federation, 119991
Sponsors and Collaborators
I.M. Sechenov First Moscow State Medical University
Investigators
Principal Investigator: Irina V Kuznetsova Sechenov First Moscow Medical University
  More Information

Publications:
Responsible Party: Kuznetsova Irina, Senior Research Fellow, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT03043690     History of Changes
Other Study ID Numbers: AMSUCC2
First Submitted: February 2, 2017
First Posted: February 6, 2017
Last Update Posted: October 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kuznetsova Irina, I.M. Sechenov First Moscow State Medical University:
menopause
ammonium succinate