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

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Menopause Related Conditions

Treatments: Dietary Supplement: Ammonium succinate; Other: Placebo

Study type: Observational

Funder types: Other

Identifiers

NCT03043690

AMSUCC2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 227 patients

Sex: Female

Ages: 42 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

227 participants in 2 patient groups

Ammonium succinate

Description:

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.

Treatment:

Dietary Supplement: Ammonium succinate

Placebo

Description:

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.

Treatment:

Other: Placebo