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

Not Applicable

Completed

• Conditions: Menopausal and Postmenopausal Disorders
• Interventions: Drug: 1mg 17 beta-estradiol; Drug: Dydrogesterone; Drug: micronized progesterone

• Registration Number: NCT02086032
• Lead Sponsor: Chiang Mai University

Brief Summary

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.

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-13
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-28
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
micronized progesterone	1mg 17 beta-estradiol	1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.
dydrogesterone	1mg 17 beta-estradiol	1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
dydrogesterone	Dydrogesterone	1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.
micronized progesterone	micronized progesterone	1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.

Primary Outcome Measures

Name	Time	Method
Improving of sleeping quality (assessed by the PSQI score)	from March 2014 up to 15 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University; 🇹🇭 Muang, Chiang Mai, Thailand