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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

Protocol summary

Summary
The present clinical, randomized, double-blind, placebo-controlled trial aimed to determine the effect of melatonin on the climactrec symptoms and sexual dysfunction in menopausal women. The study population included the menopausal women from 40 to 60 years old attending the selected gynecology clinics of Shiraz University of Medical Sciences which had agreed to cooperate with the researchers. The study subjects were also required to have the following criteria: at least 12 months being passed from their last menstrual, FSH>40, a score of 28 or below in the female sexual function index, and Greene scale score of at least 21. In case the study subjects suffered from any illness, were not willing to continue participating in the study, and showed allergic reactions to medication, they were excluded from the study. After all, a total of 240 subjects were entered into the study and randomly divided into two groups of 120 receiving the drug and the placebo, respectively. At the beginning of the study, all the subjects' physical health was examined through physical examinations. Then, 3 milligram tablets of melatonin and the placebo of melatonin were given to the case and the control group, respectively for 3 months. Before and after the intervention, blood samples were taken from all the participants in order to investigate their FSH and estradiol. Moreover, the primary outcomes included climactrec symptoms as well as sexual function which were measured through questionnaires both before and during the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201041548N13
Registration date: 2012-08-01, 1391/05/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-01, 1391/05/11
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputyof Shiraz University of medical sciense
Expected recruitment start date
2012-01-04, 1390/10/14
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Melatonin on climactric symptoms and sexual disfunction
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 40 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
ct-90-5880

Health conditions studied

1

Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Symptoms such as flushing, sleeplessness, headache, lack of concentration, associated with menopause

Primary outcomes

1

Description
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.

Secondary outcomes

1

Description
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

Intervention groups

1

Description
Intervention group: 3 milligram tablets of melatonin every night between 6 and 9 P.M. for 3 months
Category
Other

2

Description
Control group: 3 milligram tablets of placebo of melatonin every night between 6 and 9 P.M. for 3 months
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahhari Clinic
Full name of responsible person
Street address
Namazi sq.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Deputy for Research, seventh Floor, the central structure of Shiraz University of Medical Sciences, next to the Red Crescent, Zand Avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Khadijeh Abdali
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71164742528
Fax
Email
abdalikh@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine
Full name of responsible person
Dr Sedigheh Amoei
Position
Assistant Professor, Infertility Fellowship
Other areas of specialty/work
Street address
School of Medicine, Imam Hossein Square, Zand Avenue
City
Shiraz
Postal code
Phone
+98 71 1230 5410
Fax
Email
sedighehamooee@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Nehla Parandavar
Position
Master's degree in Midwifery
Other areas of specialty/work
Street address
Namazi Sq
City
Shiraz
Postal code
Phone
+98 71164742528
Fax
Email
Shaghayegh_ne.2001@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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