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Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women

Protocol summary

Summary
The aim of this study was to compare the effect of Tibolone and conventional hormone therapy on climacteric symptoms in postmenopausal women. Inclusion criteria: married, menopause after 40years old and 12 months amenorrhea or 6 month amenorrhea and serum Estradiol less than 50 pg/dl. Exclusion criteria: any history of active hepatitis, cardiovascular, inflammation disease (infectious or uninfectious), thoromboambolic or cerebrovascular disorder, psychosis, hyper-lipidemia, history of chemotherapy or radiation, HRT treatment in previous 6 months, use of vitamin E, fluoxetine , soy menopause, Propranolol and another herbal or chemical drug, smoking, alcohol or addiction. A total of 154 healthy postmenopausal women with no absolute contraindication for hormone replacement therapy (HRT) were divided into 3 groups: group A: Continuous conjugated estrogen (CE) 0.625mg plus medroxyprogestrone acetate (MPA) 2.5mg (N=48), group B: Tibolone 2.5mg/day (N=53) and group C: placebo group received only Ca-D (500 mg +200 IU) for six months. In this study At baseline and after 6 months of treatment Blood was collected for sex hormone determinations. Climacteric symptoms and Sexual function were assessed by Greene Climacteric Scale and Female Sexual Function Index (FSFI) respectively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809032766N1
Registration date: 2010-04-26, 1389/02/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-26, 1389/02/06
Registrant information
Name
Sedigheh Moghasemi
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0354
Email address
moghasemi-s@parastari.gehd.org
Recruitment status
Recruitment complete
Funding source
Tarbiat Maodares University
Expected recruitment start date
2006-12-22, 1385/10/01
Expected recruitment end date
2008-08-21, 1387/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of conventional hormone replacement therapy and tibolone on climacteric symptoms and sexual dysfunction in postmenopausal women
Public title
Comparative effects of 2 types of hormone replacement therapy on climacteric symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: married, menopause after 40 years old and 12 months amenorrhea or 6 month amenorrhea and serum Estradiol less than 50 pg/dl. Exclusion criteria: any history of active hepatitis, cardiovascular, inflamation disease (infectious or uninfectious), thoromboambolic or cerebrovascular disorder, psychosis, hyperlipidemia, history of chemotherapy or radiation, HRT treatment in previous 6 months, use of vitamine E, fluxitine, soymenopause,propranolol and another herbal or chemical druge, smoking, alchol or addiction
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Jalal Ale Ahmad Highway
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
64983/50

Health conditions studied

1

Description of health condition studied
menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
climacteric symptom
Timepoint
6 month
Method of measurement
Greene Climacteric Scale & Female Sexual Function Index

Secondary outcomes

1

Description
sex hormone status & sex hormone-binding globulin (SHBG)
Timepoint
6 month
Method of measurement
biochemistry

Intervention groups

1

Description
group A: Continuous conjugated estrogen (CE) 0.625mg plus medroxyprogestrone acetate (MPA) 2.5mg
Category
Treatment - Drugs

2

Description
group B: Tibolone 2.5mg/day
Category
Treatment - Drugs

3

Description
group C (placebo group):Ca-D (500 mg +200 IU)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fajr & Boali hospitals, Shahid Haidari & Aboraihan polyclinics, a private clinic
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Maodares University
Full name of responsible person
Dr. Yaghoub Fatolahi
Street address
Jalal Ale Ahmad Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Maodares University
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
Golestan University of Medical Sciences
Full name of responsible person
Sedigheh Moghasemi
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Shastkola Road, Hirkan boulevard
City
Gorgan
Postal code
49465-568
Phone
+98 17 1443 0351
Fax
Email
moghasemi.s@gmail.com & nasim_908@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Saedeh Ziaei
Position
Ob & gynocologist/proffesor
Other areas of specialty/work
Street address
Tarbiat Maodares University, Jalal Ale Ahmad highway
City
Tehran
Postal code
Phone
+98 218011001
Fax
Email
ziaei_99@yahoo.com & ziaei_sa@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sedigheh Moghasemi
Position
MSc
Other areas of specialty/work
Street address
Golestan University of Medical Sciences
City
Gorgan
Postal code
Phone
Fax
Email
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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