NCT00391417

Brief Summary

The purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
431

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

October 24, 2006

Status Verified

October 1, 2006

First QC Date

October 20, 2006

Last Update Submit

October 20, 2006

Conditions

Hot Flashes

Keywords

hot flushhot flashestrogenvaginal atrophy

Outcome Measures

Primary Outcomes (3)

  • Mean change from baseline in number of daily moderate to severe hot flushes.

  • Mean change from baseline in daily hot flush severity.

  • Mean change from baseline in vulvovaginal atrophy symptoms.

Secondary Outcomes (6)

  • Percent change from baseline in daily moderate to severe hot flush rates over time.

  • Percent change from baseline in hot flush severity over time.

  • Proportion of subjects with fifty to one hundred percent reductions in daily moderate to severe hot flushes.

  • Proportion of subjects with fifty to one hundred percent reductions in hot flush severity

  • Mean change from baseline in subject vaginal health self assessment over time.

  • +1 more secondary outcomes

Interventions

estradiol gelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • serum estradiol level less than or equal to 20 pg per mL
  • serum FSH greater than 40 mIU per mL

You may not qualify if:

  • Pathological cancer findings on screening
  • abnormal endometrium
  • serious hepatic, renal or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Simon JA, Bouchard C, Waldbaum A, Utian W, Zborowski J, Snabes MC. Low dose of transdermal estradiol gel for treatment of symptomatic postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):588-96. doi: 10.1097/01.AOG.0000254160.62588.41.

    PMID: 17329509DERIVED

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

September 1, 2003

Study Completion

April 1, 2005

Last Updated

October 24, 2006

Record last verified: 2006-10