Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy of FITOGYN vs. placebo on the vasomotor symptomatology associated with menopause, to evaluate the symptoms of anxiety, the metabolic parameters in menopause and to evaluate the quality of life associated to the vasomotor symptoms of menopause.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Casen-Fleet S.L.U.
• Collaborators: Apices Soluciones S.L.; Asociacion Colaboracion Cochrane Iberoamericana
• Treatments: Glycine

Criteria

Inclusion Criteria:

• Women between 45 and 60 years of age.

• Women in, the immediate or established postmenopausal phase, defined as women with: a) 12 months or more spontaneous amenorrhea or b) 6 months or more spontaneous amenorrhea with levels of follicular stimulating hormone (FSH) above 40 mIU / ml.

• Women with between 35 and 70 episodes of hot flashes (9 or more hot flashes should be of at least moderate intensity) in the week prior to the pre-inclusion period with placebo

• Women who have given written informed consent.

Exclusion Criteria:

• Women with surgical menopause.

• Treatment with HRT within 6 months of the screening visit.

• Patients who needs oncological or immunosuppressive treatment during the expected follow-up period.

• Patient with difficult follow-up or with psycho-neurological problems that hinder proper assessment (alcoholism, depression not caused by menopause, etc.)

• Patients who, at the discretion of the investigator, can not be evaluated according to criteria established in this protocol

• Patients following a vegetarian diet

• Patients with any relevant gastrointestinal disease

• Patients with a prior diagnosis of hypothyroidism or other clinically relevant thyroid disorder.

• Patients treated and / or diagnosed or with suspicion of cancer.

• Patients with diabetes mellitus who require insulin therapy.

• Patients with current diagnosis of an affective disorder (e.g. depression), anxiety disorder, or psychotic disorder.

• Patients with an organic mental disorder

• Patients with neuropathic pain or any other form of pain that receive or need treatment with antidepressives or anticonvulsivants.

• Patients receiving or requiring treatment with antidepressives or anticonvulsivants for other motives (for example, prevention of the migraine).

• Patients consuming more than 2 alcoholic drinks (16-20 gr.) per day

• Patients who have been treated with antibiotics within 3 months of the screening visit.

• Patients receiving or requiring treatment with clonidine or vitamin E.

• Patients who are treated with NSAIDs

• Patients allergic to any of the components of FITOGYN

• Patients who took less than 80% of the capsules in the pre-inclusion period with placebo.

• Patients whose weekly number of hot flushes is reduced by 25% or more during the pre-inclusion period as compared to the week prior to the initiation of that period.