Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)

NCT00668603 | Completed DMC

• 2 other identifiers: U1030N1016HUS-231911
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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

1. 1.to compare vascular, cardiac and sympathetic function in recently menopausal women with or without severe vasomotor symptoms
2. 2.in a randomized placebo controlled clinical trial investigate vascular response to oral and trans-dermal HT.

Conditions

Postmenopausal Vasomotor Symptoms; Cardiovascular Disease

Keywords

Postmenopausal vasomotor symptoms; Hot flush; Vascular function; Cardiac function; Cardiovascular risk factor

Outcome Measures

Primary Outcomes (1)

• Vascular function

  0 and 6 months

Secondary Outcomes (1)

• Cardiac and sympathetic function

  0 and 6 months

Study Arms (2)

2

EXPERIMENTAL

Postmenopausal women with severe vasomotor symptoms

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

Drug: 17-b-estradiol; Drug: 17-b-estradiol + medroxyprogeterone acetate; Drug: 17-b-estradiol hemihydrate; Drug: placebo pill + gel

Interventions

17-b-estradiol DRUG

2mg oral daily for 6 months

1; 2

17-b-estradiol + medroxyprogeterone acetate DRUG

2mg E2 + 5mg MPA daily for 6 months

Also known as: Indivina

1; 2

17-b-estradiol hemihydrate DRUG

1 mg skin gel daily for 6 months

Also known as: Divigel

1; 2

placebo pill + gel DRUG

placebo daily for 6 months

1; 2

Eligibility Criteria

• Age: 48 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• smoking
• hysterectomy
• dyslipidemia
• overt hypertension (blood pressure \> 140/90)
• diabetes
• any regular medication
• HT in the previous 3 months
• body mass index over 27

Sponsors & Collaborators

• University of Helsinki: lead
• Päivikki and Sakari Sohlberg Foundation, Finland: collaborator
• Emil Aaltonen Foundation: collaborator
• Finnish Medical Foundation: collaborator

Study Sites (1)

Helsinki University Hospital, Department of Obstetrics and Gynecology

Helsinki, Helsinki, 00029 HUS, Finland

Location

Related Publications (6)

• 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.

  PMID: 11861031 BACKGROUND

• Mikkola 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.

  PMID: 16417418 BACKGROUND

• Collins 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.

  PMID: 17644507 BACKGROUND

• Tuomikoski 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.

  PMID: 20443719 DERIVED

• Tuomikoski 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.

  PMID: 19888035 DERIVED

• Tuomikoski 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.

  PMID: 19305337 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hot Flashes

Interventions

Estradiol; Gels

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Tomi S Mikkola, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

FI (1)