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

May 28, 2017 updated by: Ekachai Leeangkoonsathian, Chiang Mai University

Investigators have found that sleeping disorder is an important problem in menopausal women.

There have been papers reporting the effect of hormonal therapy on sleeping, but fews have reported the effect of different progestogens on sleeping quality. There is a need for more in-depth study and more conclusive evidence about the progestins which have the most beneficial effects on sleeping disorders in menopausal women.

This study is going to collect the data from newly identified menopausal patients who are eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The affects of the therapy will be monitored for 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 used sleep enhancing medicine
  • recently used psychotic medicine

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: micronized progesterone
1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
Drug: 1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
Other Names:
  • Estrogen
Drug: micronized progesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users
Other Names:
  • Utrogestan
Experimental: dydrogesterone
1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
Drug: 1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
Other Names:
  • Estrogen
Drug: Dydrogesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
Other Names:
  • Duphaston

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improving of sleeping quality (assessed by the PSQI score)
Time Frame: from March 2014 up to 15 months
from March 2014 up to 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The side effects comparing the 2 arms.
Time Frame: from March 2014 up to 15 months
Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change
from March 2014 up to 15 months
The climacteric symptoms comparing the 2 arms.
Time Frame: from March 2014 up to 15 months
self reported of hot flash, fatigue and weakness
from March 2014 up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Tawiwan Pantasri, MD, Faculty of Medicine, Chiang Mai University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 1, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 28, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBG-2556-02070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Menopausal and Postmenopausal Disorders

Clinical Trials on 1mg 17 beta-estradiol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe