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CompletedNCT00564031HRTUpdated Nov 27, 2007

Hormonal Replacement Therapy and Small Artery Function

A Phase 3 interventional study of Femanest and gestapuran in Menopause, sponsored by Karolinska University Hospital. Completed at 1 site in Sweden. Open to female participants aged 50 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-11-27.

Sponsored by Karolinska University Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Menopause

Keywords

  • hormone replacement therapy; endothelial function;
03

In context

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: placebo

  • Experimental
    2

    Drug: Femanest

  • Experimental
    3

    Drug: gestapuran

  • Experimental
    4

    Drug: Femanest plus Gestapuran

Interventions

  • DrugFemanest

    2mg/day

  • Druggestapuran

    5mg/day

  • Drugplacebo

    daily

  • DrugFemanest plus Gestapuran

    combined daily

06

What researchers measure

Primary outcomes

  1. endothelium-dependent dilatation

    Time frame: 3 month

Secondary outcomes

  1. pressure-induced tone and vascular morphology

    Time frame: 3 month

07

Study locations

1 site
  • Karolinska University hospital-huddinge
    Stockholm, 14186, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00564031
Lead sponsor
Karolinska University Hospital
First posted
Nov 27, 2007
Start date
Jan 2003
Completion
Aug 2004
Last update
Nov 27, 2007

Study contacts

Karolina Kublickiene, MD PhD
principal investigator · Karolinska University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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