Menopausal symptoms Signs and Symptoms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged between 45 and 59 years old 2. Presenting with a subjective complaint of problematic menopausal symptoms for a minimum of three days per week for a period of at least 3 months 3. Presence of: marked impaired daytime functioning, hot flushes, appetite loss, sleepiness, nausea, dizziness, tiredness, dry mouth, abnormal sweating, constipation, trouble sleeping, nervousness, mood changes, vaginal changes, urinary incontinence
Exclusion criteria
Exclusion criteria: 1. Evidence that menopausal symptoms are directly related to a severe or unstable medical disorder or severe psychiatric disorder (e.g.,bipolar disorder, schizophrenia) 2. Presence of sleep apnea or periodic limb movements during sleep 3. Presence of major depression or other severe psychopathology 4. Patients receiving HRT, clonidine, SSRI medications (antidepressants), Isoflavone containing supplements, Omega 3 or 6 supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity was assessed using a Menopause Rating Scale (MRS) which measures menopausal or climacteric symptoms in a standardized way and was validated some years ago. It aims to establish an instrument that measures health-related quality of life that can easily be completed. The original German scale has been translated into English and culturally adapted. Assessed at baseline, 1 month, 2 months and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of the intervention assessed at baseline, 1 month, 2 months and 3 months | — |
Countries
United Kingdom