NCT00185237

Brief Summary

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_3

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

September 9, 2005

Last Update Submit

December 22, 2014

Conditions

Hot Flashes

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

  • Relative change in frequency of hot flushes

    12 weeks

Secondary Outcomes (7)

  • Change in intensity of hot flushes

    12 weeks

  • Changes in vaginal pH

    12 weeks

  • Changes in vaginal maturation index

    12 weeks

  • Occurrence of urogenital symptoms

    12 weeks

  • Change in MENQOL (menopausal quality of life questionaire)

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Menostar (estradiol transdermal delivery system)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Menostar (estradiol transdermal delivery system)DRUG

Menostar (estradiol transdermal delivery system (SHP00577E), 0.014 mg/day)

Arm 1
PlaceboDRUG

Placebo patch

Arm 2

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of postmenopausal status

You may not qualify if:

  • Contraindication to estrogen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hot Flashes

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 23, 2014

Record last verified: 2014-12