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OpenTrials
Completed

NCT Number: NCT02086032

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

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.

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Key information

Conditions

Menopausal and Postmenopausal Disorders

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Muang, Chiang Mai, 50200, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1mg 17 beta-estradiol

Drug

Comparing sleeping quality between micronized progesterone and dydrogesterone users.

Other names: Estrogen

Dydrogesterone

Drug

Comparing sleeping quality between micronised progesterone and dydrogesterone users.

Other names: Duphaston

Micronized progesterone

Drug

Comparing sleeping quality between micronised progesterone and dydrogesterone users

Other names: Utrogestan

Primary outcomes

  1. Improving of sleeping quality (assessed by the PSQI score)

    Time frame: from March 2014 up to 15 months

Secondary outcomes

  1. 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

  2. The climacteric symptoms comparing the 2 arms.

    Time frame: from March 2014 up to 15 months

    self reported of hot flash, fatigue and weakness

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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