MedPath

The effect of Melatonin on climactric symptoms and sexual disfunctio

Phase 2
Conditions
menopause.
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause
Registration Number
IRCT201201041548N13
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
240
Inclusion Criteria

having general health according to the Goldberg's questionnaire; i.e., getting <23 score, Greene scale score of at least 21, being married and between 40 and 60 years old, not using vitamin supplements, not using soya, getting a score of 28 or below in female sexual function index, not having used hormone therapy during the last 3 months, not using anti-depression, tranquilizer, hypnotic, and antihypertensive drugs, being healthy after the physical examinations, amenorrhea for at least 6 months, and FSH>40. Exclusion criteria: Suffering from liver, kidney, and digestive diseases, inability to continue taking medication for any reason, unwillingness to cooperate after the beginning of the study, and showing allergic reactions to medication.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
aboratory and clinical signs of menopause. Timepoint: Before intervention,1 ,2 and 3 month after intervention. Method of measurement: –In this study, climactric symptoms were measured through Greene questionnaire and female sexual function index questionnaire was used in order to assess the subjects' sexual function. In addition, FSH and EST were measured based on the international units.
Secondary Outcome Measures
NameTimeMethod
Improvement of clinical symptoms. Timepoint: Before intervention,1,2 and 3 month after intervention. Method of measurement: Completed questionnaires before and during 3 months after clinical symptoms and laboratory measurements before and after intervention.
© Copyright 2025. All Rights Reserved by MedPath