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IRCT201201041548N13 IRCT 2012-08-01 Shiraz University of Medical Sciences The effect of Melatonin on climactric symptoms and sexual disfunction Investigation of the effect of melatonin on the climacteric symptoms and sexual disfunction in menopausal woman attending in selected Gynecology Clinics of Shiraz University of medical sciences, 1390 2012-01-04 anticipated 240 Complete https://irct.ir/trial/839 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2 menopause. Intervention 1: Intervention group: 3 milligram tablets of melatonin every night between 6 and 9 P.M. for 3 months. Intervention 2: Control group: 3 milligram tablets of placebo of melatonin every night between 6 and 9 P.M. for 3 months.
public Khadijeh Abdali
Namazi Sq.
Shiraz Iran (Islamic Republic of) +98 71164742528 abdalikh@sums.ac.ir Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz scientific Dr Sedigheh Amoei
School of Medicine, Imam Hossein Square, Zand Avenue
Shiraz Iran (Islamic Republic of) +98 71 1230 5410 sedighehamooee@gmail.com School of Medicine Iran (Islamic Republic of) 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. 40 years 60 years Female N95.1 Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause Other Other Intervention group: 3 milligram tablets of melatonin every night between 6 and 9 P.M. for 3 months Control group: 3 milligram tablets of placebo of melatonin every night between 6 and 9 P.M. for 3 months Laboratory 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. 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. Shiraz University of Medical Sciences Approved 2011-12-10 Medical Research Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences Shiraz Iran (Islamic Republic of)