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

Chiang Mai University

Status: Completed

Conditions: Menopausal and Postmenopausal Disorders

Treatments: Drug: 1mg 17 beta-estradiol; Drug: Dydrogesterone; Drug: micronized progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02086032

OBG-2556-02070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

micronized progesterone

Experimental group

Description:

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

Treatment:

Drug: micronized progesterone

Drug: 1mg 17 beta-estradiol

dydrogesterone

Experimental group

Description:

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

Treatment:

Drug: Dydrogesterone

Drug: 1mg 17 beta-estradiol