Clinical Trials Logo
  1. Home
  2. Menopause Related Conditions
  3. NCT03043690

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

Menopause Related Conditions Clinical Trial

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.

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03043690
Study type Observational
Source I.M. Sechenov First Moscow State Medical University
Contact
Status Completed
Phase N/A
Start date February 11, 2017
Completion date May 30, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT05617287 - An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause N/A
Withdrawn NCT04258410 - Quercetin for Cardio-Skeletal Muscle Health and Estrogen Deficiency Phase 4
Recruiting NCT05912309 - Effects of Time-restricted Eating and Exercise Training on Skeletal Muscle Mass Quantity, Quality and Function in Postmenopausal Women With Overweight and Obesity N/A
Completed NCT04079218 - Accelerated Genital Tract Aging in HIV: Estradiol Clinical Trial Phase 4
Active, not recruiting NCT03681678 - Laser Therapy for Treatment of Urogenital Symptoms in Women
Completed NCT03082040 - A Home-based Breathing Training on Menopausal Symptoms N/A
Recruiting NCT06048965 - Asia Pacific Menopause Federation Menopause Consensus
Terminated NCT03037554 - The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women N/A
Completed NCT03150407 - Use of J3 Bioscience Lubricating Intravaginal Ring VR101 to Relieve the Symptoms of Vaginal Dryness N/A
Completed NCT04336891 - Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Not yet recruiting NCT04190927 - A New Hormone Replacement Paradigm: Physiologic Restoration Study Phase 4
Completed NCT03178695 - Inovium Ovarian Rejuvenation Trials Phase 1
Completed NCT05408273 - Vitamin D and Microvascular Function in Postmenopausal Women
Recruiting NCT04031456 - Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients Phase 2/Phase 3
Recruiting NCT05062057 - Menopause Racing Heart Study
Completed NCT05396261 - a Flexible Wound Dressing for the Management of Genital Skin Conditions N/A
Completed NCT06154798 - World Digital Detox Program for Enhancing Women's Health & Well-being N/A
Completed NCT03752060 - The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women N/A
Recruiting NCT06074120 - Low-level Laser Therapy in Genitourinary Symptoms of Menopause N/A
Recruiting NCT06192329 - Hot Water Therapy for the Treatment of Menopause-related Hot Flashes N/A