Hormonal Replacement Therapy and Small Artery Function | NCT00564031

Studies
Hormonal Replacement Therapy and Small Artery Function

NCT00564031

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Nov 27, 2007Estimated

Enrollment

66Actual

Phase

Phase 3

Conditions

Menopause

Interventions

Femanest
gestapuran
placebo
Femanest plus Gestapuran

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
166/99

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Nov 26, 2007

First Submission Date that Met QC Criteria

Nov 26, 2007

First Posted Date

Nov 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2007

Last Update Posted Date

Nov 27, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Endothelial dysfunction in resistance arteries in women after the menopause is important for the development of high blood pressure and cardiovascular disease

Detailed Description

We aim to study the effects of different hormone replacement therapies (HRT) on the function and morphology of resistance arteries, and to look for their mechanistic basis. We expect that HRT with estrogens or in combination with MPA may benefit the function of resistance arteries and may preserve the morphological integrity of endothelial cells by regulatory actions on the cytoskeleton.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Placebo Comparator	Drug: placebo
2	Experimental	Drug: Femanest
3	Experimental	Drug: gestapuran
4	Experimental	Drug: Femanest plus Gestapuran

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femanest	Drug	2mg/day	2
gestapuran

Measure	Description	Time Frame
endothelium-dependent dilatation		3 month

Measure	Description	Time Frame
pressure-induced tone and vascular morphology		3 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women had been amenorrheic for at least 1.5 year.
Menopausal status was confirmed by a serum concentration of follicular- stimulating hormone (FSH > 34 IU/ml) and estradiol (E2 <50 pmol/l).

Exclusion Criteria:

Cigarette smokers and women with:
- Hypertension
- Diabetes mellitus
- Clinical manifestations of arteriosclerosis (coronary heart disease, peripheral artery disease, or cerebrovascular disease)
- Venous thromboembolic disease
- Liver disorders
- Unexplained vaginal bleeding; and
- Personal or family history of breast cancer were excluded.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karolina Kublickiene, MD PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University hospital-huddinge		Stockholm		14186	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D017258	Medroxyprogesterone Acetate

Ancestor Terms

ID	Term
D008525	Medroxyprogesterone
D006908	Hydroxyprogesterones
D011374	Progesterone
D011282	Pregnenediones

Browse Leaves

Not provided

Browse Branches

Not provided