The effect of different groups of progestin on sleeping of menopausal women

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20140224006
• Date of registration: 24/02/2014
• Prospective Registration: Yes
• Primary sponsor: Faculty of medicine, Chiang Mai University
• Public title: The effect of different groups of progestin on sleeping of menopausal women
• Scientific title: The effect of different groups of progestin on sleeping of menopausal women
• Date of first enrolment: 03/03/2014
• Target sample size: 100
• Recruitment status: Pending (Not yet recruiting)
• URL: https://www.thaiclinicaltrials.org/show/TCTR20140224006
• Study type: Interventional
• Study design: Randomized
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Ekachai Leeangkoonsathian
• Affiliation: Department of obstetrics and gynaecology, Maharaj Nakorn Chiang Mai Hospital

• Name: Ekachai Leeangkoonsathian
• Affiliation: Department of obstetrics and gynaecology, Maharaj Nakorn Chiang Mai Hospital

Key inclusion & exclusion criteria

Inclusion criteria: New menopausal patients at Maharaj Nakorn Chiang Mai Hospital
suitable for estrogen plus progesterone treatment
Exclusion criteria: contraindication for hormone replacement therapy
recently use sleep drug
recently use psychotic drug

Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Menopausal and Postmenopausal Disorders
Sleeping quality
menopause
climacteric
progestin
dydrogesterone
micronized progesterone

Sleeping quality
menopause
climacteric
progestin
dydrogesterone
micronized progesterone

Intervention(s)

1 mg 17 beta-estradiol plus 100 mg micronized progesterone oral once a day for 3 months.,1mg 17 beta-estradiol plus 10 mg dydrogesterone oral once a day for 3 months.

Experimental Drug,Experimental Drug

micronized progesterone,dydrogesterone

Primary Outcome(s)

Improving of sleeping quality (assessed by the PSQI score) Patient reported outcome using a questionnaire interview

Secondary Outcome(s)

The side effect and climacteric symptoms comparing between 2 arms. Patient reported outcome using a questionnaire interview

Source(s) of Monetary Support

Faculty of medicine, Chiang Mai University

Secondary Sponsor(s)

Reproductive medicine unit, Obsterics and Gynecology department, Maharaj Nakon Chiang Mai Hospital

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Research Ethics Committee 4

[phone] Ext.

Results

• Date Completed: 30/04/2015