Menopausal and Postmenopausal DisordersNCT02086032
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
A study testing 1mg 17 beta-estradiol, Dydrogesterone and micronized progesterone in people with Menopausal and Postmenopausal Disorders, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal and Postmenopausal Disorders
- What is being tested?
- 1mg 17 beta-estradiol, Dydrogesterone and micronized progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
- suitable for estrogen plus progesterone treatment
Who cannot join
- contraindication for hormone replacement therapy
- recently used sleep enhancing medicine
- recently used psychotic medicine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University
Muang, Chiang Mai, 50200
About this study
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.
Read the 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.
- Conditions
- Menopausal and Postmenopausal Disorders
- Being tested
- 1mg 17 beta-estradiol, Dydrogesterone, micronized progesterone
- Keywords
- Sleeping quality, menopause, climacteric, progestin, dydrogesterone, micronized progesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1mg 17 beta-estradiolDrug
Also called Estrogen
Comparing sleeping quality between micronized progesterone and dydrogesterone users.
DydrogesteroneDrug
Also called Duphaston
Comparing sleeping quality between micronised progesterone and dydrogesterone users.
micronized progesteroneDrug
Also called Utrogestan
Comparing sleeping quality between micronised progesterone and dydrogesterone users
| Study group | Role | What they receive |
|---|---|---|
| micronized progesterone | Experimental | 1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months. Receives: Drug: 1mg 17 beta-estradiol; Drug: micronized progesterone |
| dydrogesterone | Experimental | 1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months. Receives: Drug: 1mg 17 beta-estradiol; Drug: Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving of sleeping quality (assessed by the PSQI score)
Measured: from March 2014 up to 15 months
Secondary outcomes (2)
The side effects comparing the 2 arms.
Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change
Measured: from March 2014 up to 15 months
The climacteric symptoms comparing the 2 arms.
self reported of hot flash, fatigue and weakness
Measured: from March 2014 up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal and Postmenopausal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekachai Leeangkoonsathian, Chiang Mai University
- Investigators
- Tawiwan Pantasri, MD, Principal investigator, Faculty of Medicine, Chiang Mai University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086032
- Sponsor's protocol ID
- OBG-2556-02070
- Status last verified
- May 2017
- First submitted
- 1 Mar 2014
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leeangkoonsathian E, Pantasri T, Chaovisitseree S, Morakot N. The effect of different progestogens on sleep in postmenopausal women: a randomized trial. Gynecol Endocrinol. 2017 Dec;33(12):933-936. doi: 10.1080/09513590.2017.1333094. Epub 2017 Jun 13.
PubMed 28609128
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Progestin on Sleeping of Menopausal Women
- ClinicalTrials.gov ID
- NCT02086032
- Acronym / sponsor ID
- OBG-2556-02070
- Conditions
- Menopausal and Postmenopausal Disorders
- Keywords
- Sleeping quality, menopause, climacteric, progestin, dydrogesterone, micronized progesterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronized progesterone | Experimental | Drug: 1mg 17 beta-estradiol, Drug: micronized progesterone1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months. |
| dydrogesterone | Experimental | Drug: 1mg 17 beta-estradiol, Drug: Dydrogesterone1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
- suitable for estrogen plus progesterone treatment
Key exclusion criteria (3 listed)
- contraindication for hormone replacement therapy
- recently used sleep enhancing medicine
- recently used psychotic medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1mg 17 beta-estradiolAlso: EstrogenComparing sleeping quality between micronized progesterone and dydrogesterone users. | Drug | dydrogesterone, micronized progesterone |
| DydrogesteroneAlso: DuphastonComparing sleeping quality between micronised progesterone and dydrogesterone users. | Drug | dydrogesterone |
| micronized progesteroneAlso: UtrogestanComparing sleeping quality between micronised progesterone and dydrogesterone users | Drug | micronized progesterone |
Primary outcome
Improving of sleeping quality (assessed by the PSQI score)
Time frame: from March 2014 up to 15 months
2 secondary outcomes
The side effects comparing the 2 arms.
Time frame: from March 2014 up to 15 months
The climacteric symptoms comparing the 2 arms.
Time frame: from March 2014 up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Derived from this study: PubMed 28609128Leeangkoonsathian E, Pantasri T, Chaovisitseree S, Morakot N. The effect of different progestogens on sleep in postmenopausal women: a randomized trial. Gynecol Endocrinol. 2017 Dec;33(12):933-936. doi: 10.1080/09513590.2017.1333094. Epub 2017 Jun 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tawiwan Pantasri, MD principal investigator
Faculty of Medicine, Chiang Mai University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1mg 17 beta-estradiol, Dydrogesterone and micronized progesterone in people with Menopausal and Postmenopausal Disorders, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving of sleeping quality (assessed by the PSQI score) (time frame: from March 2014 up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.