Completed

The Effect of Different Types of Progestin on Sleeping of Menopausal Women

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What is being tested

1mg 17 beta-estradiol

+ Dydrogesterone

+ micronized progesterone

Drug
Who is being recruted

From 40 to 65 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorChiang Mai University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

New patients who are eligible for hormonal therapy will be selected. They will be allocated randomly into 2 different groups, each group being prescribed 1 of 2 regimens of hormonal therapy: * 17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day * 17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and once a month for 3 months. The first and third PSQI score will be analysed.

Official TitleThe Effect of Different Types of Progestin on Sleeping of Menopausal Women
NCT02086032
Principal SponsorChiang Mai University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
suitable for estrogen plus progesterone treatment
3 exclusion criteria prevent from participating
contraindication for hormone replacement therapy
recently used sleep enhancing medicine
recently used psychotic medicine

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.

Group II

Experimental
1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University

Muang, ThailandOpen Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University in Google Maps
CompletedOne Study Center