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

Menopausal and Postmenopausal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086032
• Other study ID #: OBG-2556-02070
• Status: Completed
• Phase: N/A
• First received: March 1, 2014
• Last updated: May 28, 2017
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: May 2017
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Menopausal and Postmenopausal Disorders

Intervention

Drug:
• 1mg 17 beta-estradiol
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
• Dydrogesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
• micronized progesterone
Comparing sleeping quality between micronised progesterone and dydrogesterone users

Locations

Country	Name	City	State
Thailand	Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University	Muang	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving of sleeping quality (assessed by the PSQI score)		from March 2014 up to 15 months
Secondary	The side effects comparing the 2 arms.	Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change	from March 2014 up to 15 months
Secondary	The climacteric symptoms comparing the 2 arms.	self reported of hot flash, fatigue and weakness	from March 2014 up to 15 months