Postmenopausal Vasomotor SymptomsSYMPTOMNCT00668603
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)
A study testing 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate and 17-b-estradiol hemihydrate in people with Postmenopausal Vasomotor Symptoms and Cardiovascular Disease, run by University of Helsinki at 1 site in Finland.
Trial summary
Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. Read more about this study
- Who is it for?
- Ages 48 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Vasomotor Symptoms, Cardiovascular Disease
- What is being tested?
- 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate and 17-b-estradiol hemihydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2005to Mar 2008
- 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 48 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postmenopausal women between ages 48-55
- Minimum of 6 months and maximum of 36 months from last menstrual period
- Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l
- Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless
Who cannot join
- smoking
- hysterectomy
- dyslipidemia
- overt hypertension (blood pressure > 140/90)
- diabetes
- any regular medication
- HT in the previous 3 months
- body mass index over 27
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital, Department of Obstetrics and Gynecology
Helsinki, Helsinki, 00029 HUS
About this study
Official title: Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study
Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.
Aims of the present project are
- to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
- in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.
Read the detailed description
We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.
- Being tested
- 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate, 17-b-estradiol hemihydrate, placebo pill + gel
- Keywords
- Postmenopausal vasomotor symptoms, Hot flush, Vascular function, Cardiac function, Cardiovascular risk factor
- Medical subject headings
- Cardiovascular Diseases, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-b-estradiolDrug
2mg oral daily for 6 months
17-b-estradiol + medroxyprogeterone acetateDrug
Also called Indivina
2mg E2 + 5mg MPA daily for 6 months
17-b-estradiol hemihydrateDrug
Also called Divigel
1 mg skin gel daily for 6 months
placebo pill + gelDrug
placebo daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Postmenopausal women with severe vasomotor symptoms Receives: Drug: 17-b-estradiol; Drug: 17-b-estradiol + medroxyprogeterone acetate; Drug: 17-b-estradiol hemihydrate; Drug: placebo pill + gel |
| 1 | Experimental | Postmenopausal women without vasomotor symptoms Receives: Drug: 17-b-estradiol; Drug: 17-b-estradiol + medroxyprogeterone acetate; Drug: 17-b-estradiol hemihydrate; Drug: placebo pill + gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Measured: 0 and 6 months
Secondary outcomes (1)
Cardiac and sympathetic function
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal Vasomotor SymptomsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, Emil Aaltonen Foundation, Finnish Medical Foundation
- Responsible party
- Principal investigator, Tomi S. Mikkola, University of Helsinki
- Investigators
- Tomi S Mikkola, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668603
- Sponsor's protocol ID
- U1030N1016
- Other IDs
- HUS-231911
- Acronym
- SYMPTOM
- Status last verified
- Feb 2016
- First submitted
- 24 Apr 2008
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002 Feb 15;53(3):605-19. doi: 10.1016/s0008-6363(01)00466-7.
PubMed 11861031Mikkola TS, Clarkson TB. Coronary heart disease and postmenopausal hormone therapy: conundrum explained by timing? J Womens Health (Larchmt). 2006 Jan-Feb;15(1):51-3. doi: 10.1089/jwh.2006.15.51. No abstract available.
PubMed 16417418Collins P, Rosano G, Casey C, Daly C, Gambacciani M, Hadji P, Kaaja R, Mikkola T, Palacios S, Preston R, Simon T, Stevenson J, Stramba-Badiale M. Management of cardiovascular risk in the peri-menopausal woman: a consensus statement of European cardiologists and gynaecologists. Eur Heart J. 2007 Aug;28(16):2028-40. doi: 10.1093/eurheartj/ehm296. Epub 2007 Jul 20.
PubMed 17644507Tuomikoski P, Mikkola TS, Tikkanen MJ, Ylikorkala O. Hot flushes and biochemical markers for cardiovascular disease: a randomized trial on hormone therapy. Climacteric. 2010 Oct;13(5):457-66. doi: 10.3109/13697131003624656.
PubMed 20443719Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Effect of hot flushes on vascular function: a randomized controlled trial. Obstet Gynecol. 2009 Oct;114(4):777-785. doi: 10.1097/AOG.0b013e3181b6f268.
PubMed 19888035Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Evidence for a role of hot flushes in vascular function in recently postmenopausal women. Obstet Gynecol. 2009 Apr;113(4):902-908. doi: 10.1097/AOG.0b013e31819cac04.
PubMed 19305337
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT00668603
- Acronym / sponsor ID
- SYMPTOM / U1030N1016
- Keywords
- Postmenopausal vasomotor symptoms, Hot flush, Vascular function, Cardiac function, Cardiovascular risk factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, Emil Aaltonen Foundation, Finnish Medical Foundation
- Study start
- Aug 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 29 Apr 2008 (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.
Recent large randomized, placebo-controlled studies assessing the health effects of HT question the overall benefits of long term HT, especially with respect to cardiovascular disease. However, recently menopausal women with severe hot flushes were mostly excluded from these trials. This was unfortunate since vasomotor symptoms may reflect different vascular sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in women with and without hot flushes can differ.
Aims of the present project are
- to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
- in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.
Detailed description
We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80 comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor assessments will be done, including clinical assessment of autonomic nervous system, endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and various other vascular surrogate marker measurements. In the first part of the study we compare these baseline measurements between women with or without severe vasomotor symptoms. In the second part of the study the women are randomized to receive placebo, oral estrogen, oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the baseline assessments are repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: 17-b-estradiol, Drug: 17-b-estradiol + medroxyprogeterone acetate, Drug: 17-b-estradiol hemihydrate, Drug: placebo pill + gelPostmenopausal women with severe vasomotor symptoms |
| 1 | Experimental | Drug: 17-b-estradiol, Drug: 17-b-estradiol + medroxyprogeterone acetate, Drug: 17-b-estradiol hemihydrate, Drug: placebo pill + gelPostmenopausal women without vasomotor symptoms |
Who may qualify
- Ages
- 48 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Postmenopausal women between ages 48-55
- Minimum of 6 months and maximum of 36 months from last menstrual period
- Postmenopausal status of these women will be confirmed by level of FSH that should exceed 30 U/l
- Eighty women must have severe vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas eighty comparators must be symptomless
Key exclusion criteria (8 listed)
- smoking
- hysterectomy
- dyslipidemia
- overt hypertension (blood pressure > 140/90)
- diabetes
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 |
|---|---|---|
| 17-b-estradiol2mg oral daily for 6 months | Drug | 1, 2 |
| 17-b-estradiol + medroxyprogeterone acetateAlso: Indivina2mg E2 + 5mg MPA daily for 6 months | Drug | 1, 2 |
| 17-b-estradiol hemihydrateAlso: Divigel1 mg skin gel daily for 6 months | Drug | 1, 2 |
| placebo pill + gelplacebo daily for 6 months | Drug | 1, 2 |
Primary outcome
Vascular function
Time frame: 0 and 6 months
1 secondary outcome
Cardiac and sympathetic function
Time frame: 0 and 6 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 19 Feb 2016.
- Background: PubMed 11861031Mikkola TS, Clarkson TB. Estrogen replacement therapy, atherosclerosis, and vascular function. Cardiovasc Res. 2002 Feb 15;53(3):605-19. doi: 10.1016/s0008-6363(01)00466-7.
- Background: PubMed 16417418Mikkola TS, Clarkson TB. Coronary heart disease and postmenopausal hormone therapy: conundrum explained by timing? J Womens Health (Larchmt). 2006 Jan-Feb;15(1):51-3. doi: 10.1089/jwh.2006.15.51. No abstract available.
- Background: PubMed 17644507Collins P, Rosano G, Casey C, Daly C, Gambacciani M, Hadji P, Kaaja R, Mikkola T, Palacios S, Preston R, Simon T, Stevenson J, Stramba-Badiale M. Management of cardiovascular risk in the peri-menopausal woman: a consensus statement of European cardiologists and gynaecologists. Eur Heart J. 2007 Aug;28(16):2028-40. doi: 10.1093/eurheartj/ehm296. Epub 2007 Jul 20.
- Derived from this study: PubMed 20443719Tuomikoski P, Mikkola TS, Tikkanen MJ, Ylikorkala O. Hot flushes and biochemical markers for cardiovascular disease: a randomized trial on hormone therapy. Climacteric. 2010 Oct;13(5):457-66. doi: 10.3109/13697131003624656.
- Derived from this study: PubMed 19888035Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Effect of hot flushes on vascular function: a randomized controlled trial. Obstet Gynecol. 2009 Oct;114(4):777-785. doi: 10.1097/AOG.0b013e3181b6f268.
- Derived from this study: PubMed 19305337Tuomikoski P, Ebert P, Groop PH, Haapalahti P, Hautamaki H, Ronnback M, Ylikorkala O, Mikkola TS. Evidence for a role of hot flushes in vascular function in recently postmenopausal women. Obstet Gynecol. 2009 Apr;113(4):902-908. doi: 10.1097/AOG.0b013e31819cac04.
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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.
Tomi S Mikkola, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 17-b-estradiol, 17-b-estradiol + medroxyprogeterone acetate and 17-b-estradiol hemihydrate in people with Postmenopausal Vasomotor Symptoms and Cardiovascular Disease, run by University of Helsinki at 1 site in Finland.
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 4 inclusion and 8 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 19 Feb 2016. 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 Finland. 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?
Vascular function (time frame: 0 and 6 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 NCT00668603, which also lists 6 linked publications.
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 19 Feb 2016.