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

NCT ID: NCT03043690

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 227 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-11
• Study Completion Date: 2017-05-30

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.

Conditions

Menopause Related Conditions

Keywords

menopause; ammonium succinate

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Ammonium succinate

Intervention Type: 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

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.

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kuznetsova Irina

Senior Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irina V Kuznetsova

Role: PRINCIPAL_INVESTIGATOR

Sechenov First Moscow Medical University

Locations

Sechenov First Moscow Medical University

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 27759458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22343510 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 19434881 (View on PubMed)

Other Identifiers

AMSUCC2

Identifier Type: -

Identifier Source: org_study_id