NCT00564031

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

November 26, 2007

Last Update Submit

November 26, 2007

Conditions

Menopause

Keywords

hormone replacement therapy; endothelial function;

Outcome Measures

Primary Outcomes (1)

  • endothelium-dependent dilatation

    3 month

Secondary Outcomes (1)

  • pressure-induced tone and vascular morphology

    3 month

Study Arms (4)

1

PLACEBO COMPARATOR
Drug: placebo

2

EXPERIMENTAL
Drug: Femanest

3

EXPERIMENTAL
Drug: gestapuran

4

EXPERIMENTAL
Drug: Femanest plus Gestapuran

Interventions

FemanestDRUG

2mg/day

2
gestapuranDRUG

5mg/day

3
placeboDRUG

daily

1
Femanest plus GestapuranDRUG

combined daily

4

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University hospital-huddinge

Stockholm, 14186, Sweden

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

MedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Karolina Kublickiene, MD PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

January 1, 2003

Study Completion

August 1, 2004

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

SE(1)