Clinical trial NCT03043690: A Pooled Analysis of the Data From Two Studies of Ammonium Succinate for Menopausal Symptoms
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause Related Conditions
Keywords: menopause
ammonium succinate
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 227
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: "Heart beating quickly and strongly" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Feeling tense or nervous" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Difficulty in sleeping" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Excitable" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Attacks of panic" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Difficulty in concentrating" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Feeling tired or lacking in energy" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Loss of interest in most things" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Feeling unhappy or depressed" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Crying spells" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Irritability" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Feeling dizzy or faint" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Pressure or tightness in head or body" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Parts of body feeling numb or tingling" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Headaches" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Muscle or joint pains" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Loss of feeling in hands or feet" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Breathing difficulties" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Hot flushes" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Sweating at night" symptom (Greene Climacteric Scale)
timeFrame: Week 12
measure: "Loss of interest in sex" symptom (Greene Climacteric Scale)
timeFrame: Week 12
Secondary outcomes:
measure: Spilberger-Hanin (Situational anxiety)
timeFrame: Week 12
measure: Spilberger-Hanin (Personal anxiety)
timeFrame: Week 12
measure: Spilberger-Hanin (Actual anxiety)
timeFrame: Week 12
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov First Moscow Medical University
Study officials:
affiliation: Sechenov First Moscow Medical University
name: Irina V Kuznetsova
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1080/09513590.2016.1232686.
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.
citation: Greene JG. Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84. doi: 10.1016/j.maturitas.2008.09.011.