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

• Sponsor: Chiang Mai University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02086032
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menopausal and Postmenopausal Disorders	Drug: 1mg 17 beta-estradiol; Drug: Dydrogesterone; Drug: micronized progesterone	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Different Types of Progestin on Sleeping of Menopausal Women
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improving of sleeping quality (assessed by the PSQI score) [from March 2014 up to 15 months]

Secondary Outcome Measures

1. The side effects comparing the 2 arms. [from March 2014 up to 15 months]

   Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change

2. The climacteric symptoms comparing the 2 arms. [from March 2014 up to 15 months]

   self reported of hot flash, fatigue and weakness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University	Muang	Chiang Mai	Thailand	50200

Sponsors and Collaborators

• Chiang Mai University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ekachai Leeangkoonsathian, MD, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT02086032
• Other Study ID Numbers: OBG-2556-02070
• First Posted: Mar 13, 2014
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Keywords provided by Ekachai Leeangkoonsathian, MD, Chiang Mai University: Sleeping quality; menopause; climacteric; progestin; dydrogesterone; micronized progesterone
• Additional relevant MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Estrogens; Progesterone; Dydrogesterone

Study Results

No Results Posted as of May 31, 2017